Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775016
Status:
TERMINATED
Last Update Posted:
2023-05-16
First Post:
2023-03-07
Brief Title:
Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women
Sponsor:
Lindenwood University
Organization:
Lindenwood University
Study Overview
Official Title:
Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women on Changes in Body Composition Glucose Control and Cardiometabolic Risk Factors
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to the withdrawal of funding which made it impossible to continue the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LBC
Brief Summary:
Beta-amino isobutyric acid BAIBA is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel We seek to examine changes in body composition weight loss glucose control and cardiometabolic risk factors after adding supplementation of BAIBA to exercise in overweight and obese men and women
Detailed Description:
This study will be conducted using a double-blind placebo-controlled parallel group design Eligible study participants will be randomly assigned to one of three supplementation groups placebo resistant dextrin supplementation exercise group 750 mg BAIBA supplementation exercise group and a 1500 mg BAIBA supplementation exercise group After signing an IRB-approved consent form prospective participants will be scheduled for a screening visit where they will have their eligibility finalized through completion of a peak VO2 assessment using a motorized treadmill and metabolic cart Eligible participants will then be fully explained the study and scheduled for a baseline testing session week 0 Prior to scheduling this visit participants must complete a 4-day food record Once a food record is completed participants will observe an overnight fast and be scheduled to complete the testing session between the hours of 0600 - 1000 hours Upon arrival changes in medical status medications and dietary supplements will be confirmed before having their body mass and hemodynamics assessed Next participants will have their waist circumference body water BIS and body composition DEXA assessed to evaluate changes in body composition and obesity status throughout the study protocol Participants will then have a venous blood sample collected for evaluation of health markers complete blood counts comprehensive metabolic panels and lipid panels before completing a resting metabolic rate measurement The resting metabolic rate measurement will be used to prescribe energy intake throughout the study protocol Participants will then use an electronic tablet and complete the Profile of Mood States and visual analog scales to evaluate perceptions of hunger and appetite Participants will then be given their first daily dose All participants will be given instructions and meal plans as well as be offered weekly educational sessions on how to restrict calories and meet protein goals throughout the study protocol Participants will complete five days per week of exercise consisting of a mixture of walking and resistance training Daily compliance to the exercise and supplementation groups will be monitored weekly for a 12-week period Participants who complete at least 80 of their assigned workouts will be considered compliant and will be scheduled for follow-up visits after 6 and 12 weeks of supplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None