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Exercise + Supplements for Obesity (GOP Trial)

N/A

Recruiting

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

In good health absent of being overweight or mildly obese with no other signs or symptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders

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

Must not have

Has liver disease or some form of clinically diagnosed hepatic impairment

Current smoker (average of > 1 pack per day within the past 3 months) or has quit within the past six months. This includes all forms of nicotine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Summary

This trial will test if adding supplements to exercise helps overweight and obese people lose weight & improve their health.

Who is the study for?

This trial is for overweight and obese men and women aged 18-60, with a BMI of >25 to <32 kg/m2. Participants should be in good health without major diseases or disorders, not pregnant, planning pregnancy, or lactating, free from substance abuse history within the last year, not on certain medications like statins or for weight loss, non-smokers for at least six months.

What is being tested?

The study tests if adding L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise supplements to an 8-week exercise program affects body composition, weight loss, and cardio-metabolic risk factors in overweight/obese individuals.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to dietary supplements such as digestive discomfort. Exercise can cause muscle soreness or injury if not done properly.

Eligibility Criteria

Inclusion Criteria

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

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I am in good health, not overweight or mildly obese, with no chronic diseases.

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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.

Exclusion Criteria

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

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I have liver disease or a diagnosed liver condition.

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I currently smoke more than a pack a day or quit within the last six months.

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I have or am being treated for heart disease.

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

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I have a history of neurological conditions or diseases.

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

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

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

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

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I have been diagnosed with diabetes.

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

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I am not taking any medications or supplements for weight loss.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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

Body Mass

Complete Blood Count

Comprehensive Metabolic Panel

+11 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 500 mg BAIBA supplementation + 40 mg Grains of ParadiseExperimental Treatment1 Intervention

500 mg BAIBA supplementation + 40 mg Grains of Paradise

Group II: 500 mg BAIBA supplementationExperimental Treatment1 Intervention

500 mg BAIBA supplementation

Group III: PlaceboPlacebo Group1 Intervention

Resistant starch

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lindenwood UniversityLead Sponsor

18 Previous Clinical Trials

633 Total Patients Enrolled

1 Trials studying Obesity

23 Patients Enrolled for Obesity

Chad M Kerksick, PhDPrincipal InvestigatorLindenwood University

7 Previous Clinical Trials

235 Total Patients Enrolled

1 Trials studying Obesity

23 Patients Enrolled for Obesity

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05775003 — N/A

Obesity Research Study Groups: Placebo, 500 mg BAIBA supplementation + 40 mg Grains of Paradise, 500 mg BAIBA supplementation

Obesity Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05775003 — N/A

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05775003 — N/A

~0 spots leftby Oct 2024

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