BAIBA + Exercise for Obesity

(LBC Trial)

Overseen By Chad M Kerksick, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lindenwood University

Must not be taking: Statins, Hypertension medications

Disqualifiers: Heart disease, Diabetes, Cancer, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a supplement called BAIBA, combined with exercise, can aid weight loss and improve health factors like blood sugar control in overweight and obese individuals. Participants will be divided into groups to receive either a placebo or different doses of the BAIBA supplement. The researchers aim to determine if adding BAIBA to regular exercise enhances weight and health outcomes. The trial seeks men and women who are overweight or mildly obese, active without assistance, and free of major health conditions. As an unphased trial, participants can contribute to groundbreaking research that may lead to new health solutions.

Will I have to stop taking my current medications?

The trial requires that participants not be currently prescribed statin drugs or any hypertension medications. If you are taking these, you would need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that L-BAIBA, the main treatment in this trial, has been safe in earlier studies. One study found that a dose of 900 mg per kilogram per day did not cause harmful effects in animals. Another study with mice demonstrated that L-BAIBA was well-tolerated even at doses of 100 mg per kilogram per day over 15 weeks. Although this isn't the exact dose used in human trials, it provides insight into how the body might handle this compound over time.

These studies suggest that L-BAIBA is generally safe, but human trials are essential to confirm this. For those considering joining this trial, existing research on L-BAIBA appears promising in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Mitoburn (L-BAIBA) for obesity because it represents a novel approach compared to typical treatments like lifestyle changes, medications, or bariatric surgery. Mitoburn is unique because it introduces L-BAIBA, a naturally occurring molecule in the body known to enhance fat burning and improve metabolism. This treatment stands out because it may amplify the effects of exercise, offering a potential dual-action benefit that could lead to more effective weight management. With two different doses under investigation, 750 mg/day and 1,500 mg/day, researchers hope to determine the optimal amount needed to maximize these benefits safely.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will evaluate the effects of L-BAIBA combined with exercise for obesity management. Research has shown that L-BAIBA, a compound produced during exercise, helps convert white fat into brown fat, which burns more calories. This conversion can improve insulin handling and aid in weight loss. Studies also indicate that L-BAIBA boosts energy storage in muscles, providing more energy post-exercise. When paired with exercise, L-BAIBA has effectively reduced body fat and improved heart and metabolic health. This suggests that L-BAIBA could be a valuable addition to exercise routines for managing obesity and related health risks. ^{2 3 6 7 8}

Who Is on the Research Team?

Chad M Kerksick, PhD

Principal Investigator

Lindenwood University

Are You a Good Fit for This Trial?

This trial is for overweight and obese men and women, aged 18-60, with a BMI between >25.0 to <32.0 kg/m2 who are generally healthy without major diseases or disorders. Participants should be able to exercise safely and not be on certain medications like statins or have a history of substance abuse.

Inclusion Criteria

I can move around on my own, with or without help from devices like canes or walkers.

Your body mass index (BMI) is between 25 and 32, which means you are overweight or obese.

I am in good health, not overweight or mildly obese, and have no major health issues.

Exclusion Criteria

I have been diagnosed with an immune disorder like HIV/AIDS.

I have liver disease or a diagnosed liver condition.

Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Testing

Participants complete baseline testing including body composition and metabolic assessments

1 week

1 visit (in-person)

Treatment

Participants receive supplementation and engage in exercise for 12 weeks

12 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• L-BAIBA

Trial Overview The study tests the effects of adding L-BAIBA supplement to regular exercise on body composition, weight loss, glucose control, and cardiometabolic risk factors in adults struggling with obesity.

How Is the Trial Designed?

Group I: 750 mg/day Mitoburn (L-BAIBA) Experimental Treatment 1 Intervention

750 mg/day Mitoburn (L-BAIBA)

Group II: 1,500 mg/day Mitoburn (L-BAIBA) Experimental Treatment 1 Intervention

1,500 mg/day Mitoburn (L-BAIBA)

Group III: Placebo Placebo Group 1 Intervention

Placebo (Resistant Dextrin) (n=40)

Who Is Running the Clinical Trial?

Lindenwood University

Lead Sponsor

Trials

22

Recruited

830+

Published Research Related to This Trial

Exercise has numerous benefits for individuals with obesity, including aiding in weight loss and improving cardiovascular health, but the direct impact on weight loss from exercise alone is modest, typically resulting in only a few kilograms of weight loss.

Physical activity is crucial for managing type 2 diabetes and preventing its complications, and a structured approach like the 5 A's strategy can help healthcare professionals effectively support patients in overcoming barriers to increasing their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. Oppert, JM., Bellicha, A., Ciangura, C.[2021]

A network meta-analysis of 45 randomized controlled trials involving 3566 participants found that while any exercise is better than no exercise for people with obesity, the weight loss achieved is generally modest.

Combining high-intensity aerobic exercise with high-load resistance training was shown to be the most effective approach for reducing abdominal fat, improving lean body mass, and enhancing cardiorespiratory fitness, suggesting this combination should be prioritized in exercise prescriptions for adults with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What exercise prescription is optimal to improve body composition and cardiorespiratory fitness in adults living with obesity? A network meta-analysis. O'Donoghue, G., Blake, C., Cunningham, C., et al.[2021]

A systematic review of 116 studies found that both aerobic and anaerobic training significantly improve body composition and physical fitness in individuals with obesity, with effect sizes ranging from trivial to very large.

Physical training not only reduces body weight and fat mass but also increases fat-free mass and VO2max, indicating enhanced cardiovascular fitness, suggesting that various intensities of exercise can be beneficial for weight loss and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. Zouhal, H., Ben Abderrahman, A., Khodamoradi, A., et al.[2021]

Increased physical activity, particularly moderate-intensity aerobic exercise, can improve metabolic health in obese individuals by increasing good cholesterol (HDL) and lowering bad cholesterol (VLDL), insulin levels, and blood pressure.

A multifactorial approach that combines exercise, nutrition education, and behavior modification is essential for effective weight management and long-term adherence to healthy lifestyle changes in individuals with mild to moderate obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More exercise for the obese? Kukkonen-Harjula, K.[2006]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0006291X24012750

A derivative of L-BAIBA significantly alleviating high-fat diet ... Oct-B shows 80x greater efficacy than L-BAIBA in reducing obesity. •. Oct-B reduces lipid accumulation, upregulates UCP1 in adipose tissue. •. Oct ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05775016

Effects of Adding L-BAIBA to Exercising Adult Overweight ... We seek to examine changes in body composition, weight loss, glucose control, and cardiometabolic risk factors after adding supplementation of BAIBA to exercise ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5832359/

β-aminoisobutyric Acid, L-BAIBA, Is a Muscle-Derived ... The exercise-induced muscle factor β-aminoisobutyric acid (BAIBA) plays a critical role in the browning of white fat and in insulin resistance.

4. blog.priceplow.com blog.priceplow.com/supplement-research/mitoburn-glycogen-supercompensation

New Research on MitoBurn's Metabolic Benefits New research shows MitoBurn (L-BAIBA) from NNB Nutrition significantly enhances glycogen storage after exercise.

5. withpower.com withpower.com/trial/phase-metabolic-syndrome-2-2023-29aef

BAIBA + Exercise for Obesity (LBC Trial) Combining high-intensity aerobic exercise with high-load resistance training was shown to be the most effective approach for reducing abdominal fat, improving ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/10915818221094487

Safety Assessment of L-β-Aminoisobutyric Acid (L-BAIBA) Based on the results, the No-Observed-Adverse-Effect Level (NOAEL) of L-BAIBA was 900 mg/kg/day. Introduction. Beta-aminoisobutyric acid (also ...

7. ctv.veeva.com ctv.veeva.com/study/effects-of-adding-l-baiba-to-exercising-adult-overweight-and-obese-men-and-women

Effects of Adding L-BAIBA to Exercising Adult Overweight and ... We seek to examine changes in body composition, weight loss, glucose control, and cardiometabolic risk factors after adding supplementation of BAIBA to ...

8. vediclifesciences.com vediclifesciences.com/experience/l-baiba/

Safety Assessment of L-β-Aminoisobutyric Acid (L-BAIBA) The present study was designed to evaluate the safety and toxic potentials of this compound, where L-BAIBA was administered orally to Sprague Dawley rats.