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

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether a muscle-produced substance called BAIBA can help overweight and obese people lose weight and improve their health when combined with exercise. Participants will take different doses of BAIBA while following an exercise routine. The study aims to see if BAIBA can make the body better at using energy and burning fat. BAIBA has shown similar cardioprotective effects to exercise in previous studies.

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.

What data supports the effectiveness of the treatment BAIBA + Exercise for Obesity?

Research shows that physical activity, including both aerobic and resistance training, helps with weight loss, reduces body fat, and improves fitness in people with obesity. Combining high-intensity aerobic and resistance training is particularly effective in reducing abdominal fat and improving overall fitness. ^{1 2 3 4 5}

Is BAIBA safe for humans?

BAIBA, a compound produced during exercise, has shown no toxic effects in animal studies, with a high safety level observed in rats. While human-specific safety data is limited, these findings suggest it is generally safe. ^{6 7 8 9 10}

How does the treatment of exercise differ from other treatments for obesity?

Exercise, when combined with BAIBA, is unique because it not only aids in weight loss but also helps preserve lean body mass and improve cardiovascular health. Unlike some treatments that focus solely on weight reduction, exercise enhances overall fitness and metabolic health, making it a comprehensive approach to managing obesity. ^{3 11 12 13 14}

Research Team

Chad M Kerksick, PhD

Principal Investigator

Lindenwood University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of physical training on anthropometrics, physical and physiological capacities in individuals with obesity: A systematic review. [2021]

2. England 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of the past 25 years of weight loss research using diet, exercise or diet plus exercise intervention. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Pre-operative Exercise Intervention on Patient Outcomes Following Bariatric Surgery: a Systematic Review and Meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

β-aminoisobutyric acid attenuates LPS-induced inflammation and insulin resistance in adipocytes through AMPK-mediated pathway. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Beta-Aminoisobutyric Acid as a Novel Regulator of Carbohydrate and Lipid Metabolism. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A low-calorie diet raises β-aminoisobutyric acid in relation to glucose regulation and leptin independent of exercise in women with obesity. [2023]

9. England pubmed.ncbi.nlm.nih.gov

β-aminoisobutyric acid attenuates hepatic endoplasmic reticulum stress and glucose/lipid metabolic disturbance in mice with type 2 diabetes. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Safety Assessment of L-β-Aminoisobutyric Acid (L-BAIBA): Subchronic Toxicity Study in Sprague Dawley Rats. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The Effect of Aerobic Training and Green Tea Supplementation on Cardio Metabolic Risk Factors in Overweight and Obese Females: A Randomized Trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Exercise training in the management of overweight and obesity in adults: Synthesis of the evidence and recommendations from the European Association for the Study of Obesity Physical Activity Working Group. [2021]

13. Finland pubmed.ncbi.nlm.nih.gov

More exercise for the obese? [2006]

14. United States pubmed.ncbi.nlm.nih.gov

Exercise Training Does Improve Cardiorespiratory Fitness in Post-Bariatric Surgery Patients. [2022]