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BAIBA + Exercise for Obesity (LBC 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
Free-living/uninhibited with use of ambulatory assistive devices and independent
Participants who are between 18 - 60 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
LBC Trial Summary
This trial will examine how adding BAIBA supplementation to exercise affects body composition, weight loss & cardiometabolic risk in overweight & obese people.
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.Check my eligibility
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.See study design
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.
LBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can move around on my own, with or without help from devices like canes or walkers.
Select...
I am between 18 and 60 years old.
Select...
I am in good health, not overweight or mildly obese, and have no major health issues.
LBC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fat Mass (4-compartment)
Secondary outcome measures
4-Compartment Lean mass
Body Mass
Comprehensive Metabolic Panel
+8 moreLBC 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
~760
Find a Location
Who is running the clinical trial?
Lindenwood UniversityLead Sponsor
18 Previous Clinical Trials
646 Total Patients Enrolled
Chad M Kerksick, PhDPrincipal InvestigatorLindenwood University
7 Previous Clinical Trials
248 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can move around on my own, with or without help from devices like canes or walkers.I have been diagnosed with an immune disorder like HIV/AIDS.I have liver disease or a diagnosed liver condition.Your body mass index (BMI) is between 25 and 32, which means you are overweight or obese.I am between 18 and 60 years old.I am in good health, not overweight or mildly obese, and have no major health issues.I have not had any cancer, except for skin cancer without spread or cervical cancer that hasn't spread, in the last 5 years.I have no physical limitations that would stop me from joining a fitness program.I am currently receiving treatment for kidney disease or undergoing dialysis.I have a history of neurological conditions or diseases.I quit smoking less than 6 months ago, after smoking more than a pack a day.I have been diagnosed with or am being treated for thyroid disease.I have been diagnosed with diabetes.I was hospitalized for a mental health issue in the last year.The average body size of everyone in the study will be less than a certain number.You have had problems with drinking alcohol or using drugs in the past year.I am currently taking medication for high cholesterol or high blood pressure.I cannot swallow or digest food properly due to a GI tract issue.I am not taking any weight loss drugs or supplements.I am willing and able to follow the study's requirements and procedures.You have been doing intense exercise or lost a lot of weight in the past three months.I have or am being treated for heart disease.You can do an exercise test without any health issues that would prevent you from exercising, according to the American College of Sports Medicine.Your body mass index (BMI) falls between 25.0 and 32.0, which means you are overweight or obese.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 750 mg/day Mitoburn (L-BAIBA)
- Group 3: 1,500 mg/day Mitoburn (L-BAIBA)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05775016 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to participate in this clinical investigation?
"This clinical trial requires 120 participants with a BMI of 30 or more and between the ages 18 to 60."
Answered by AI
Is this research initiative targeting individuals of legal age or older?
"This trial has strict age requirements, whereby the minimum and maximum ages for enrollment are 18 and 60 respectively."
Answered by AI
Are any prospective participants being welcomed into this trial?
"Sadly, this clinical trial's enrollment period has closed. Initially posted on March 15th 2023 and last updated on the 7th of March, it is not currently recruiting participants. Nevertheless, there are still 1418 other medical studies looking for volunteers at present."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Illinois
What site did they apply to?
Exercise and Performance Nutrition Laboratory
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
Interested in any weight loss study. I want to be healthier and more active.
PatientReceived 2+ prior treatments
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