Understanding Obesity and Overweight

The rise of obesity and being overweight have become global health concerns, affecting millions of individuals, especially in the United States. Did you know that 1 in 3 adults are considered obese? This alarming statistic highlights the severity of the obesity epidemic that is sweeping the nation. In this blog, we will go over the difference between overweight and obesity, their causes, risks, prevention and how Altasciences LA plays a crucial role in clinical trials.

Difference Between Overweight and Obesity

Overweight and obesity are two terms commonly used to describe ranges of weight that are greater than what is generally considered healthy for a given height. Overweight refers to having more body weight than is optimally healthy, but it is less severe than obesity. This condition is typically defined by a Body Mass Index (BMI) of 25 to 29.9. Obesity, on the other hand, is a more severe form of excess weight, where a person has accumulated enough body fat that it might have a negative effect on their health. This is generally reflected by a BMI of 30 or more. Both conditions increase the risk of numerous health problems, but the risks are greater with obesity. 

BMI Levels and Weight Classifications:

BMI Level	Weight Classification
Below 18.5	Underweight
18.5 to < 25	Healthy weight
25 to < 30	Overweight
30 and above	Obesity
40 and above	Severe obesity

You can find your BMI here.

BMI is calculated the same way for both adults and children; however, it may not be suitable for some people, such as pregnant women, athletes, and children under 18. Additionally, BMI may not provide a comprehensive assessment because it does not consider factors such as muscle mass.
 

Causes of Being Overweight and Obesity

The development of overweight and obesity is complex and can result from a combination of factors, including:

• Dietary Factors: Excess calorie intake, poor nutrition, large portion sizes, and irregular eating patterns
• Physical Activity: Sedentary lifetime and lack of exercise
• Genetics: Family history and gene variants
• Metabolic Factors: Basal metabolic rate, hormonal imbalances, age-related metabolic changes.
• Psychological Factors: Cultural norms, peer pressure, socioeconomic status
• Sleep patterns: Insufficient sleep and irregular sleep schedules.
• Age and Life Stages: Influences from childhood and adolescence, pregnancy, menopause, and aging

 

Health Risks Associated with Obesity and Being Overweight 

• Cardiovascular Diseases: Heart diseases and strokes
• Type 2 Diabetes: Insulin resistance and poor blood sugar control
• Cancer: Increased risk of breast, colorectal, and endometrial cancers
• Hypertension: High blood pressure
• Respiratory Issues: Conditions such as sleep apnea and asthma
• Joint Problems: Osteoarthritis and gout
• Mental Health Issues: Depression, social stigma, and eating disorders

 

Prevention and Management of Obesity and Overweight

Understanding the cause(s) is the first step towards reducing the risk. By adopting preventive lifestyle changes, seeking appropriate medical interventions, and creating supportive environments, individuals can take control of their health and significantly reduce the risk of being overweight and obese. These strategies collectively contribute to improved overall health and quality of life.

 

Future Directions in Overweight and Obesity Clinical Trials

While conventional treatments can be effective, researchers continually seek new and innovative methods to help people achieve and maintain a healthy weight. Clinical trials play a crucial role in these efforts, providing valuable insights into the medical condition, offering studies on obesity, testing innovative treatments, and advancing our understanding of effective weight management strategies.

Clinical trials focus on various types of interventions specifically tailored to address being overweight and obesity. Here are some examples:

• Pharmacological Interventions: Studies that test new medications or combinations of drugs.
• Behavioral Interventions: Studies on lifestyle changes, diet, and weight loss programs involving exercise.
• Surgical Interventions: Studies on bariatric surgery and its long-term effects.
• Technological Interventions: Studies involving apps, wearable devices, weight loss programs, or telehealth services to support weight management.

By exploring these emerging trends and potential future treatments, researchers are paving the way for more effective, personalized, and sustainable   for combating obesity. These innovations promise to not only treat obesity more effectively but also prevent it, offering a beacon of hope for the health and well-being of millions worldwide.

At Altasciences LA, we are actively seeking volunteers with high BMI. If you’re interested in our paid clinical trials in Los Angeles and Orange County area, click here to learn more.

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Reference: 
10 Causes of Obesity & Overweight - Healwide Clinic. https://healwideclinic.com/10-causes-of-obesity/
 

 

Understanding Cholesterol: HDL, LDL, Non-HDL, and Triglycerides - What You Need to Know About the Good, the Bad, Risks and Treatment

Cholesterol is a natural component of the blood that functions as a building block for cell membranes. The body needs cholesterol, but elevated levels of bad cholesterol can result in major health risks like a heart attack or stroke.

There are two main types of cholesterol in the body: low-density lipoprotein (LDL) and high-density lipoprotein (HDL). According to the CDC, the combination of low HDL or high LDL cholesterol can also cause health problems ^[1].

The goal of this blog is to help you learn about the different major types of cholesterol, the health risks they may cause, and possible treatment approaches.

What is HDL Cholesterol?

HDL cholesterol is commonly called “good cholesterol” because it helps the body remove bad cholesterol in the blood. This removal lowers the risk of cardiovascular or coronary artery diseases.

What is LDL Cholesterol?

LDL cholesterol is commonly called “bad cholesterol” because elevated levels of LDL cholesterol is associated with an increased risk of cardiovascular disease (heart attacks and stroke).

What are Triglycerides?

Triglycerides are a type of fat lipid in the blood. They come from foods like oils, butter, and other fats. In some cases, triglycerides could also come from extra calories that the body doesn’t need.

When the body needs energy, it releases triglycerides, and a type of LDL cholesterol carries triglycerides to the tissues. Elevated levels of triglycerides can also lead to health problems.

What is Non-HDL Cholesterol?

Your non-HDL is a combination of your LDL cholesterol levels and other bad fats in the blood called atherogenic lipoprotein particles. These particles are associated with a high risk of cardiovascular disease, even when LDL cholesterol levels are low.

Atherogenic lipoprotein particles are typically characterized by (VLDL), intermediate density IDL1, and IDL2. Non-HDL Cholesterol is calculated by subtracting your “good cholesterol” or HDL from your total cholesterol. Unlike HDL cholesterol, it’s advisable to ensure your non-HDL cholesterol range is low.  

Symptoms of High Cholesterol

There are typically no symptoms of high cholesterol. Many times, you only discover high levels of cholesterol when you visit the doctor for a lipid panel test.

Symptoms of high cholesterol in young adults and seniors may be visible if they have familial hypercholesterolemia. People with that condition typically have a cholesterol level of 300 mg/dL or more. Some of the visible symptoms of high cholesterol include ^[4]:

• Tendon xanthomas: Swellings on the knuckles of the hand, knees, or Achilles due to high cholesterol. People with sitosterolemia and cerebrotendinous xanthomatosis (CTX) may also experience the condition.

• Xanthelasmas: Small and yellow lumps of cholesterol near the eyelid skin. It has a soft, chalky, or semi-solid texture and can be removed.

• Corneal arcus: A pale white or grey ring around the Iris (colored part of the eye). It often appears denser in superior and inferior eye regions.

Dangers of High Cholesterol

High cholesterol, particularly LDL cholesterol or “bad cholesterol,” can affect proper body functioning for the:

• Cardiovascular and circulatory system

• Digestive system

• Endocrine system

• Nervous system

Cardiovascular and Circulatory System

Too much LDL cholesterol can build up in the arteries and clog them. This hardens the arteries, creating a state called atherosclerosis. Blood doesn’t flow properly through the arteries, and your heart needs to work harder to pump.

Too much work by the heart can cause chest pain called angina, which can be a warning sign of a heart attack. The clogging of the arteries leads to the formation of plaques that can also block the blood supply to the intestinal tract, legs, and feet, leading to peripheral arterial disease (PAD).

Digestive System

Cholesterol is essential in the digestive system for the production of bile, which helps your body break down food and absorb nutrients. However, when there’s too much bad cholesterol in the bile, the excess forms crystals and hard stones in the gall bladder.

Gallstones can be painful and may need surgery to remove.

Endocrine System

The endocrine system consists of tissues for creating and releasing hormones like estrogen, testosterone, and cortisol.

As estrogen levels rise during a woman’s menstrual cycle, HDL cholesterol levels begin to rise while LDL declines. This tends to be a reason for a higher risk of heart disease in women after menopause.

Lower production of thyroid hormone may also cause an increase in the total and LDL cholesterol. However, excess amounts of thyroid hormone (hyperthyroidism) cause a reverse effect.

Nervous System

Cholesterol is essential for the human brain, containing 25 percent of the body’s entire supply. This amount of cholesterol is essential to protect the nerve cells and also enables the brain to communicate with the rest of the body.

Even though cholesterol is essential for the brain, too much of it can damage parts of the brain. Symptoms of this damage may include loss of memory and movement, problems swallowing, and speech impediment.

Ideal Cholesterol Range by Age

The chart below shows the ideal approximate range of the different cholesterol types: Total, non-HDL, LDL, HDL, and Triglycerides.

Age	Total Cholesterol	Non-HDL Cholesterol	LDL Cholesterol	HDL Cholesterol	Triglycerides
19 and younger	Below 170	Below 120	Below 110	45 or higher	Below 150
20 and older (male)	125 – 200	Below 130	Below 100	40 or higher	Below 150
20 and older (female)	125 – 200	Below 130	Below 100	50 or higher	Below 150

 

HDL vs. LDL vs. Triglycerides

High levels of HDL are healthy, but LDL cholesterol combined with high triglycerides is linked to fatty buildups in artery walls.

Causes of High Triglycerides

Some common causes of high triglycerides include:

• Being overweight or obese

• Smoking cigarettes

• Thyroid diseases

• Poorly controlled type 2 diabetes

• Excessive use of alcohol

• Liver or kidney diseases

• Certain medications

• Genetic disorders

• Constantly eating more calories than you burn

High Triglyceride Symptoms

There are usually no symptoms of triglycerides before it gets complicated. So, it’s important to go for regular visits to the doctor to test for high triglycerides.

Risks of High Triglycerides

Some of the major risks of high triglycerides are:

• Atherosclerosis

• Pancreatitis

Atherosclerosis

Atherosclerosis is the slow buildup of plaque in the artery walls. As plaque builds up, the thickness of the artery wall increases.  In the early stages of the condition, the hardening of the arteries is typically unnoticeable.

According to the U.S. National Institutes of Health, 50 percent of people aged 45 to 84 years have atherosclerosis but aren’t aware of the condition ^[6].

Symptoms of atherosclerosis are not notable until the artery walls become very narrow or blocked. Based on body parts blocked, the symptoms of atherosclerosis are:

Heart

Some noticeable symptoms in the heart are:

• Shortness of breath during physical activity.

• Pain in the back, shoulders, neck, arms, or belly.

• Heart palpitations.

• Fatigue.

• Nausea or vomiting that may feel like indigestion.

 

Digestive system

Symptoms of atherosclerosis in the digestive system may include:

• Bloating

• Diarrhea

• Pain and cramping in the belly after eating

• Unintentional weight loss

 

Legs and feet

In the legs and feet, some major symptoms are:

• Muscle pain

• Changes in skin color

• Cool skin on your feet

• Sores on the feet that don’t heal

• Burning or aching pain

• Frequent skin and soft tissue infections in the legs or feet

 

Kidneys

Symptoms of atherosclerosis in the kidney are:

• Headaches

• Swelling

• Unexplained weight loss

• Nausea, vomiting, or appetite loss

• Feeling drowsy or tired

 

Brain

In the brain, some of the notable symptoms are:

• Loss of muscle strength

• Dizziness

• Severe headache

• Slurred speech or difficulty forming words

• Vision loss in one eye

Pancreatitis

Pancreatitis is a condition that causes inflammation and swelling of the pancreas. The condition occurs when enzymes or digestive juices attack the pancreas.

Pancreatitis can be acute or chronic. Symptoms of the condition typically include:

• Nausea

• Vomiting

• Fever

• Severe belly pain

• Swelling and feeling sore or tender in the upper belly

• Lowered blood pressure

• Rapid heart rate

How to Lower Bad Cholesterol and Triglycerides

In the United States, close to 25.9 percent of people have elevated blood triglycerides ^[7]. Hence, it’s evident that lowering one’s levels of triglycerides is imperative. Here are some ways to lower triglycerides as well as LDL cholesterol.

Target Attaining a Healthy Weight

Consuming excess calories ends up turning to triglycerides, which get stored as fat in the body. Working towards achieving a moderate body weight by taking in fewer calories may be an effective way out of high triglyceride levels.

Research shows that losing 5 to 10 percent of one’s body weight can significantly reduce triglycerides ^[8].

Reduce Sugar Intake

According to the American Heart Association, it’s advisable to consume no more than 100 – 150 calories of added sugar daily. However, a study showed that the average American consumes up to 308 calories daily ^[9].

Sugar-sweetened beverages are likely to contain more sugar and may increase triglyceride levels in the blood. Fortunately, slight changes like staying on a low-carb diet or replacing sugar-sweetened beverages with water can decrease triglycerides.

Exercise Regularly

Regular aerobic exercise, when paired with weight loss, may be effective at decreasing triglycerides. The American Heart Association advises getting a minimum of 30 minutes of aerobic exercise 5 days a week through walking, bicycling, swimming, and jogging ^[10].

All exercises are effective at reducing triglycerides. However, some research shows that exercising at high intensity for a short period is more effective than moderate-intensity exercises for longer periods.

Establish a Regular Meal Pattern

After a meal, insulin gets released into the bloodstream and transports sugar to the cells for energy. When the body has too much insulin, it becomes resistant to it. Insulin resistance causes the body to ineffectively produce insulin, which leads to a build-up of sugar and triglycerides in the blood.

Creating a regular meal pattern can help against insulin resistance and high triglyceride levels. For instance, not eating breakfast can help reduce insulin sensitivity.

So, regardless of how many meals one eats a day, eating regular meals may help improve overall insulin sensitivity and lower blood triglycerides.

Reduce Alcohol Intake

Alcohol contains a lot of sugar and calories. If the body doesn’t use the calories, they become triglycerides and get stored in fat cells.

Alcohol intake may also increase the synthesis of large VLDL lipoproteins in the liver, which is responsible for transporting triglycerides into the system.

It’s important to reduce or stop alcohol because even moderate consumption can increase blood triglycerides by up to 53 percent.

Foods to Lower Triglycerides

Some of the best foods for high triglycerides (foods that help lower triglyceride levels) are:

Avocado

Avocado is a healthy source of monounsaturated fatty acids. When you replace saturated fats, trans fats, and carbohydrates with an avocado, it can significantly reduce triglyceride levels.

The monounsaturated fats from avocado are also better at lowering blood sugar levels than other fat types. They help reduce risk factors for metabolic syndrome, which is a condition that increases the possibility of type 2 diabetes.

Whole Grains

Whole grains like barley, buckwheat, oatmeal, and millet are notable for their potential role in reducing the risk of heart disease. For instance, oatmeal helps reduce total cholesterol and blood sugar levels. Buckwheat and millet have also been shown to reduce triglyceride levels by up to 74 percent ^[11].

Generally, whole grains also provide fiber, vitamins, minerals, and other healthy nutrients that help maintain healthy living.

Garlic

Garlic is commonly known as a seasoning, but it also has therapeutic effects for cardiovascular health conditions. The herb has anti-hyperlipidemic properties, making it effective in reducing triglyceride and cholesterol levels.

Quinoa

Quinoa is derived from the Chenopodium quinoa plant in South America. It contains high protein content and offers antioxidant properties linked to the reduction of heart disease, obesity, and type 2 diabetes.

Soy Protein

Studies show that soy protein helps reduce high levels of triglyceride. Soybeans, edamame, tempeh, and tofu are good sources of isoflavones, a compound that promotes weight management and reduces triglycerides. Fermented soy products contain higher nutritional value than unfermented soy.

Fatty Fish

Fatty fish like mackerel, herring, salmon, and sardines are good sources of omega-3 fats, a type of healthy fat for lowering triglycerides. Besides its importance for healthy cell membranes, fatty fish also help reduce inflammation, lower cholesterol, and support a healthy brain and gut ^[12].

Coconut Oil

Coconut oil is high in saturated fats but also seems to have protective effects against heart disease. It has a mixed fatty acid profile, containing saturated fats and medium-chain triglycerides. A 2018 study revealed that coconut oil helps increase HDL cholesterol and lower LDL cholesterol ^[13].

Conclusion

The combination of high triglycerides and bad cholesterol can cause health problems. However, there are often no visible symptoms of high triglyceride or cholesterol levels. So, it is important to perform a lipid panel test regularly with a licensed medical professional. Also, ensure you have a good diet plan that includes all meals needed for keeping triglyceride and cholesterol levels low.

At Altasciences LA, we conduct studies focused on volunteers with high LDL cholesterol and triglycerides. Explore our current studies to find available opportunities. Take the first step towards finding potential treatment options by signing up today to see if you qualify.

References

1. https://www.cdc.gov/cholesterol/about/ldl-and-hdl-cholesterol-and-triglycerides.html
2. https://www.ncbi.nlm.nih.gov/books/NBK279318/#:~:text=The%20following%20levels%20are%20considered,1.3%20mmol%2FL)%20in%20women
3. https://medlineplus.gov/cholesterollevelswhatyouneedtoknow.html
4. https://www.bhf.org.uk/informationsupport/risk-factors/high-cholesterol#:~:text=There%20are%20usually%20no%20symptoms,get%20your%20cholesterol%20level%20checked.
5. https://www.niddk.nih.gov/health-information/digestive-diseases/gallstones/treatment
6. https://www.nhlbi.nih.gov/health/atherosclerosis
7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7237595/
8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7565024/
9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5039079/
10. https://health.gov/sites/default/files/2019-09/Physical_Activity_Guidelines_2nd_edition.pdf
11. https://pubmed.ncbi.nlm.nih.gov/29762481/
12. https://pubmed.ncbi.nlm.nih.gov/30400360/
13. https://pubmed.ncbi.nlm.nih.gov/29511019/

Reflecting on a Year of Progress: Highlights from Altasciences LA

Looking back on 2023, we would like to take a moment to reflect on the remarkable progress we’ve achieved together. Throughout the past year, thanks to support from our volunteers, we pursued breakthroughs in medicine, striving to advance research and develop life-saving therapeutics. Together, we've accomplished significant milestones!

A Year of Achievements: 2023 in Numbers

• Studies Conducted: We conducted 55 studies, each contributing to potentially life-saving medications and treatments.
• Participant Enrollment: 1138 participants were enrolled at LA site, including 423 new volunteers and 715 returning volunteers.
• Compensation: We highly appreciate your time and dedication. The highest compensation amount for their time and travel per person was $27,300.
• Expanding Reach: With 9 locations spanning across North America, we’re making a global impact.
• Growing Support: We received a total 84,872 sign-ups from volunteers interested in participating in our clinical trials.
• Dedicated Team: 2138 employees across all locations, including 476 new hires who've joined us to make a difference.
• Exceptional Dedication: Longest inpatient stay lasted a total of 42 nights.
• Awards & Recognition: we received 8 awards and recognitions, showcasing our dedication and leadership as a clinical research organization.

 

Advancing Drug Development: 

We are frequently asked by volunteers about the nature of medications and treatments being tested at Altasciences. Here are examples of studies conducted by our team over the course of the previous year.

• COVID-19 Treatment
• Hepatitis C Treatment
• Flu Treatment
• Rare Pediatric Seizure Disorders Treatment
• Type 2 Diabetes Treatment
• Alzheimer's Disease Treatment
• Psychedelic Drugs for Psychiatric Conditions Treatment
• Opioid Crisis and Addiction Treatment
• Non-Opioid Analgesic for Acute Pain Treatment
• Cystic Fibrosis, Chronic Kidney Disease, and Pain Treatment
• Heart Arrhythmia Treatment

 

Facility Update: Bathroom and Restroom Remodel 

We’re committed to continually improving your experience at Altasciences LA. Based on volunteers' feedback, we made several enhancements to our bathroom facilities last year. Your comfort and well-being during your stay are highly important to us.

Firstly, we expanded the countertop space and updated the vanity mirrors to ensure ample comfort and convenience for your personal needs. Additionally, we executed a comprehensive cosmetic overhaul, which involved replacing the flooring, applying fresh paint, and installing modern partitions. Moreover, we've installed a new water heating system to guarantee a consistent and reliable hot water supply, ensuring your comfort and satisfaction throughout your stay.

We will continue to make upgrades to our facility to better serve the needs of our volunteers.

 

Message from Altasciences…

As we reflect on a year filled with achievements and milestones, we want to express our deepest appreciation to our volunteers and our community for their unwavering support and trust in us. At Altasciences, your safety and well-being are top priority, as we move in unison to advance research and life-saving therapeutics.  Your invaluable contribution is the backbone of our progress and the heart of our mission.

Exploring a Day in the Life of Clinical Trials at Altasciences LA

If you’ve never participated in a clinical trial at Altasciences LA, you may wonder what a typical day as an inpatient stay looks like. While each study has its unique schedule, this blog post aims to provide you with an insightful overview of what to anticipate.

After completing the screening visit and being called back for check-in, your first step upon arrival at our facility will be to undergo a COVID-19 test. Once you receive a negative test result, you'll proceed to check-in at our building.

Following check-in, you’ll take part in orientation and be guided to your assigned room, which could be either shared or private, depending on the study’s requirements. After orientation, you can relax for the rest of the day as for most studies, treatment dosing doesn't begin until the following day.

 

Morning:

Morning typically starts early at Altasciences LA. After waking up, you may undergo a series of tests, including urine collection, COVID-19 testing, vital sign assessments, body weight measurement, blood collection and a physical examination. After these evaluations, you'll receive your medication or treatment, followed by breakfast.

 

Midday:

Depending on the specifics of the study, you may have additional tests or assessments scheduled throughout the day. As the day progresses, you’ll have periodic check-ups with our dedicated healthcare professionals, who carefully monitor your well-being, evaluate for any adverse events, and engage in discussions to address any changes or concerns. Alongside these commitments, you’ll also find plenty of free time to spare. Furthermore, it’s worth noting that lunch is provided as part of your daily experience.

 

At Altasciences LA, we prioritize the comfort and well-being of our volunteers. We understand that your time here is important, and we’ve taken steps to ensure your experience is enjoyable. To enhance your stay, we offer a dedicated entertainment room equipped with various amenities, such as a pool table, ping pong table, theater room, mini basketball arcade, video games, streaming services and more. During your leisure hours, you’re welcome to relax and make the most of these facilities, allowing you to unwind. Alternatively, you can use your own laptop, read books, relax in your bed, or engage in remote work.

Additionally, we organize engaging activities for participants involved in longer inpatient studies. One such activity is our soap-making class, offering a unique and creative way to spend your time while fostering a sense of community and fun within the clinic.

For participants with extended inpatient stays, we also provide the convenience of on-site laundry facilities to ensure your comfort and convenience throughout your time here.

 

Evening:

After enjoying your dinner, there may be additional procedures scheduled, which could involve further blood collection or urine sampling. Alternatively, you can use this time to relax and savor your evening until it's time to turn in for the night.

 

The journey of becoming a clinical trial participant here at Altasciences LA is very straightforward and accessible. It all begins with filling out a form on our website. After that, a brief phone call to identify a study that you may qualify for. Following this initial step, you'll have a screening appointment with one of our trained staff members who will address any questions or concerns you may have about the study.

Throughout your inpatient stay, our facility is staffed with licensed medical professionals available around the clock. Your health and well-being remain our topmost priorities. To explore the ongoing studies at Altasciences in Los Angeles and Orange County, please click here!

Phases of Clinical Trials

Did you know there are different phases in clinical trials and on average, it takes around 10 to 15 years from the initial discovery of a potential drug to its approval? Before any new medication or treatment can become accessible to the public, it must go through a series of clinical trial phases.

In this article, we will walk you through the different phases of clinical trials, offering insights into what each phase entails and how volunteers play a crucial role.

Phase 1:

In this phase, researchers aim to understand how a new drug or treatment interacts with the human body. Volunteers in Phase 1 are usually a small group of healthy individuals. The primary focus is to determine the safety of the treatment, its proper dosage, and any potential side effects. These trails provide valuable information that helps researchers make informed decisions before moving to the next step.

Phase 2:

Once a treatment has been deemed safe in Phase 1, Phase 2 trials involve a larger group of volunteers, including individuals who have the condition the new treatment is indicated for. The goal here is to evaluate the efficacy in treating the specific condition. Researchers closely monitor the participants and collect data on the treatment’s effectiveness, potential benefits, and any side effects.

Phase 3:

Should a treatment exhibit promising outcomes in Phase 2, it progresses to Phase 3 – the final phase before potential approval by regulatory authorities such as the FDA. This phase involves an even larger group of participants. Phase 3 trials aim to validate the treatment's effectiveness, monitor side effects on a broader scale, and compare the new treatment with existing standard treatments.

Phase 4:

After regulatory approval, Phase 4 trials continue to monitor the treatment's long-term effects, benefits, and potential risks in a larger patient population. These trials provide insights into the treatment's performance in real-world settings and help identify any rare or long-term side effects that might not have been apparent in earlier phases.

 

Each phase is conducted following a strict protocol and guidelines, aimed at ensuring not only the efficacy and safety of the new medical interventions but also the well-being and safety of the volunteers at every step.

Your participation makes a significant difference by contributing to the development of new treatments and improving the lives of many patients around the world.

 

At Altasciences LA, we offer a variety of clinical trials that you may qualify for. All studies are conducted in the Los Angeles and Orange County area. To find out more, please click here to see the studies available for participation.

Volunteer Safety in Clinical Trials: Everything You Need to Know

Clinical trials are research studies that involve volunteers to test the safety and efficacy of medical interventions, such as drugs, vaccines, and medical devices. They are crucial in the development of new treatments and therapies, and their success relies heavily on the participation of volunteers.

However, clinical trials can also involve risks that can impact the health and safety of the volunteers. Therefore, ensuring volunteer safety is a top priority in any clinical trial. In this article, we will discuss the importance of volunteer safety in clinical trials, the measures taken to ensure it, and what volunteers need to know before participating.

Risks and Benefits of Clinical Trials

Clinical trials involve risks and benefits that volunteers should be aware of before deciding to participate. The benefits of participating in a clinical trial include:

• Contributing to Medical Research
• Access to New Treatments
• Comprehensive Health Checkups
• Opportunity to Maintain a Healthy Lifestyle
• Potential Financial Benefits

To learn more about the benefits of participating in clinical trials, click here

 

The risks of participating in a clinical trial include:

• The intervention may not be effective or may have adverse side effects.
• The trial may require multiple visits and procedures, which can be time-consuming and inconvenient.
•  The volunteers may experience physical or emotional discomfort.

Ethical Considerations

Clinical trials must follow strict ethical guidelines to protect the rights and welfare of the volunteers. These guidelines include:

• Informed consent: Volunteers must be fully informed about the trial's purpose, procedures, risks, and benefits before deciding to participate. They must also have the right to withdraw at ANY TIME without penalty.
• Confidentiality: Volunteers' personal and medical information must be kept confidential and protected.

Fair selection: Volunteers must be selected based on specific criteria, such as age, gender, medical condition, and health status.

• Institutional Review Board (IRB): Clinical trials must be reviewed and approved by an IRB, an independent committee of medical professionals, scientists, and community representatives who assess the scientific validity and ethical soundness of the study 

Pre-screening and Informed Consent

Prior to participating in a clinical trial, volunteers are required to undergo a pre-screening process to determine their eligibility. This process may include medical history, physical exams, and laboratory tests. 

In some cases, certain clinical research organizations may conduct phone screenings as an initial step before scheduling an in-person screening visit. This allows them to further evaluate the volunteer's eligibility. Additionally, prior to the physical examination, the volunteers will receive detailed information about the clinical trial through the process of informed consent. 

Once the volunteers are deemed eligible, they must sign an informed consent form that explains the trial's purpose, procedures, risks, and benefits. The informed consent form must be written in clear and simple language.

Before joining a clinical trial, you will be told what to expect as a participant and everything that might happen. Our trained medical staff will explain the treatment’s possible side effects or other risks. As part of the informed consent process, it’s meant to protect our participants because you can ask questions about the trial.

After getting all this information, you can consider whether you want to participate. If you decide to move forward with the participation, you will be provided with an informed consent form to review and sign. The purpose of this form is to confirm that you have been informed about all the necessary details and that you have willingly agreed to participate in the study. It is essential to note that the informed consent form is not a contractual agreement, and you are free to withdraw from the trial at any time, for any reason, without any negative impact on your medical care or being judged.

The researchers conducting the study are also bound by ethical and legal standards to keep all your health and personal information confidential. Your privacy and confidentiality will be maintained throughout your participation in the trial. Clinical trials are fundamental in advancing medical research, and your willingness to participate can contribute to significant scientific discoveries. By understanding the informed consent process, you can make an informed decision about participating in the clinical trial.

Should I sign up for a clinical trial?

Clinical trials are a safe and important way to advance medical knowledge and improve patient care. They are carefully regulated and monitored to ensure the safety of participants, and informed consent is a critical component of the process. If you are considering participating in a clinical trial, it's important to discuss any concerns with the study team and make an informed decision based on your individual circumstances.

We understand that participating in a clinical trial can feel somewhat intimidating, especially if you have never participated before. However, we want to assure you that our team is here to support and guide you throughout the process, and we welcome any questions or concerns you may have. Please don't hesitate to contact us at ptinfo@altasciences.com or call us at 1-866-461-2526 to learn more about the medical clinical trials we offer in Los Angeles and Orange County, CA.