What side effects are associated with this type of intervention?

Common treatments for obesity that enhance metabolic processes and fuel metabolism include metformin, topiramate, liraglutide, and phentermine-topiramate. Metformin is generally well-tolerated but can cause gastrointestinal issues such as nausea and diarrhea. Topiramate may lead to cognitive side effects like memory impairment and difficulty concentrating, as well as paresthesia. Liraglutide can cause gastrointestinal symptoms, including nausea, vomiting, and diarrhea, and may increase the risk of pancreatitis. Phentermine-topiramate combination therapy can result in increased heart rate, insomnia, dry mouth, and constipation. These treatments are effective but come with varying side effect profiles that should be considered in clinical decision-making.

What prior FDA approvals exist?

Several FDA-approved treatments for obesity focus on enhancing metabolic processes and fuel metabolism. One notable example is the combination of phentermine and topiramate, which has been shown to significantly enhance weight loss by increasing energy expenditure and reducing appetite. Another example is liraglutide, a GLP-1 receptor agonist, which improves glucose control and promotes weight loss by enhancing insulin secretion and slowing gastric emptying. These treatments, like BAIBA, aim to improve metabolic health and aid in weight management.

What other types of research exist?

Promising novel alternatives to BAIBA supplementation for obesity patients include: 1) Combination of phentermine and topiramate, which has shown significant weight loss in clinical trials. 2) GLP-1 receptor agonists, such as semaglutide, which enhance insulin secretion and promote weight loss. 3) Laparoscopic Roux-en-Y gastric bypass, a surgical intervention that has demonstrated long-term weight loss and improvement in metabolic health. 4) Anamorelin, a ghrelin mimetic, which has potential benefits in appetite regulation and weight management.

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BAIBA + Exercise for Obesity (LBC Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for obesity often target metabolic processes to enhance fuel metabolism and promote weight loss. GLP-1 receptor agonists, such as liraglutide, increase insulin secretion and slow gastric emptying, leading to reduced appetite and caloric intake. Metformin improves insulin sensitivity and reduces hepatic glucose production, aiding in weight management. Phentermine-topiramate combines an appetite suppressant with a medication that enhances energy expenditure. These mechanisms are crucial for obesity patients as they address the underlying metabolic dysfunctions, leading to more effective and sustainable weight loss.

N/A

Waitlist Available

Led By Chad M Kerksick, PhD

Research Sponsored by Lindenwood University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Free-living/uninhibited with use of ambulatory assistive devices and independent

Participants who are between 18 - 60 years of age

Must not have

Diagnosed with some form of immune disorder (i.e., HIV/AIDS)

Has liver disease or some form of clinically diagnosed hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves an exercise regimen and dietary supplements (L-BAIBA), potential side effects may include muscle soreness, fatigue, gastrointestinal discomfort or allergic reactions to the supplement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 60 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have liver disease or a diagnosed liver condition.

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I have no physical limitations that would stop me from joining a fitness program.

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I am currently receiving treatment for kidney disease or undergoing dialysis.

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I have been diagnosed with or am being treated for thyroid disease.

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I have a history of neurological conditions or diseases.

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I have been diagnosed with diabetes.

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I was hospitalized for a mental health issue in the last year.

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I am currently taking medication for high cholesterol or high blood pressure.

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I cannot swallow or digest food properly due to a GI tract issue.

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I am not taking any weight loss drugs or supplements.

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I have or am being treated for heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fat Mass (4-compartment)

Secondary study objectives

4-Compartment Lean mass

Body Mass

Comprehensive Metabolic Panel

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 750 mg/day Mitoburn (L-BAIBA)Experimental Treatment1 Intervention

750 mg/day Mitoburn (L-BAIBA)

Group II: 1,500 mg/day Mitoburn (L-BAIBA)Experimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

Placebo (Resistant Dextrin) (n=40)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity often target metabolic processes to enhance fuel metabolism and promote weight loss. GLP-1 receptor agonists, such as liraglutide, increase insulin secretion and slow gastric emptying, leading to reduced appetite and caloric intake. Metformin improves insulin sensitivity and reduces hepatic glucose production, aiding in weight management. Phentermine-topiramate combines an appetite suppressant with a medication that enhances energy expenditure. These mechanisms are crucial for obesity patients as they address the underlying metabolic dysfunctions, leading to more effective and sustainable weight loss.