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Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women (LBC)

Primary Purpose

Obesity, Weight Loss, Weight, Body

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Lindenwood University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity, Weight Loss, cardiometabolic syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants who are between 18 - 60 years of age Body mass index values will range from >25.0 to < 32.0 kg/m2, making them qualified as an overweight-to-obese population (https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm) Average body mass index for entire study cohort will be less than 30.0 kg/m2. As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 30.0 kg/m2 Free-living/uninhibited with use of ambulatory assistive devices (e.g. canes, crutches, walkers, etc.) and independent 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 Willingness to maintain consistent sleep duration the evening before study visits Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures Able to complete a peak oxygen consumption exercise test with no contraindications to perform exercise per standards put forth by the American College of Sports Medicine. In other words, they are able to safety complete maximal exercise. Exclusion Criteria: Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals Has liver disease or some form of clinically diagnosed hepatic impairment Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL) Diagnosed with or is being treated for some form of thyroid disease Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year Diagnosed with some form of immune disorder (i.e., HIV/AIDS) History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) Positive medical history for any neurological condition or neurological disease Currently prescribed a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) Current smoker (average of > 1 pack per day within the past 3 months) has quit within the past six months. This includes all forms of nicotine Intake of any drugs (prescribed or over the counter) or dietary supplements that are known or are purported to weight loss such as thermogenics, hydroxycitric acid, ephedra, capsaicin, etc. Participants who are lactating, pregnant or planning to become pregnant Have a known sensitivity or allergy to any of the study products History of alcohol or substance abuse in the 12 months prior to screening Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study Recent history (<3 months) of exercise training or weight loss (> 5%) Any orthopedic limitation that would prevent participation in a general fitness program 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

Sites / Locations

  • Exercise and Performance Nutrition LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

750 mg/day Mitoburn (L-BAIBA)

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

Arm Description

Placebo (Resistant Dextrin) (n=40)

750 mg/day Mitoburn (L-BAIBA)

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

Outcomes

Primary Outcome Measures

Fat Mass (4-compartment)
Changes in Fat Mass (4-compartment)

Secondary Outcome Measures

4-Compartment Lean mass
Changes in Lean Mass (4-compartment)
Waist circumference
Changes in Waist circumference
Visceral Fat (DEXA)
Changes in Visceral Fat (DEXA)
Lean:Fat Ratio (DEXA)
Changes in Lean:Fat Ratio (DEXA)
Body Mass
Changes in Body Mass
Hunger and appetite visual analog scale
Changes in Hunger and appetite visual analog scale
Profile of mood states (POMS)
Changes in Profile of mood states (POMS)
Inflammatory markers (e.g. CRP, IL-6, etc.)
Changes in Inflammatory markers (e.g. CRP, IL-6, etc.)
Comprehensive Metabolic Panel
Changes in Comprehensive Metabolic Panel
Lipid Panel
Changes in Lipid Panel
Self-reported adverse events
Occurrences of Self-reported adverse events

Full Information

First Posted
March 7, 2023
Last Updated
May 15, 2023
Sponsor
Lindenwood University
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1. Study Identification

Unique Protocol Identification Number
NCT05775016
Brief Title
Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women
Acronym
LBC
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lindenwood University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Weight, Body, Cardiometabolic Syndrome
Keywords
Obesity, Weight Loss, cardiometabolic syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be conducted using a double-blind, placebo-controlled, parallel group design.
Masking
ParticipantInvestigator
Masking Description
Intervention will be blinded to both participant and investigators
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Resistant Dextrin) (n=40)
Arm Title
750 mg/day Mitoburn (L-BAIBA)
Arm Type
Experimental
Arm Description
750 mg/day Mitoburn (L-BAIBA)
Arm Title
1,500 mg/day Mitoburn (L-BAIBA)
Arm Type
Experimental
Arm Description
1,500 mg/day Mitoburn (L-BAIBA)
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
12 week resistance and cardiovascular exercise program
Primary Outcome Measure Information:
Title
Fat Mass (4-compartment)
Description
Changes in Fat Mass (4-compartment)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
4-Compartment Lean mass
Description
Changes in Lean Mass (4-compartment)
Time Frame
12 weeks
Title
Waist circumference
Description
Changes in Waist circumference
Time Frame
12 weeks
Title
Visceral Fat (DEXA)
Description
Changes in Visceral Fat (DEXA)
Time Frame
12 weeks
Title
Lean:Fat Ratio (DEXA)
Description
Changes in Lean:Fat Ratio (DEXA)
Time Frame
12 weeks
Title
Body Mass
Description
Changes in Body Mass
Time Frame
12 weeks
Title
Hunger and appetite visual analog scale
Description
Changes in Hunger and appetite visual analog scale
Time Frame
12 weeks
Title
Profile of mood states (POMS)
Description
Changes in Profile of mood states (POMS)
Time Frame
12 weeks
Title
Inflammatory markers (e.g. CRP, IL-6, etc.)
Description
Changes in Inflammatory markers (e.g. CRP, IL-6, etc.)
Time Frame
12 weeks
Title
Comprehensive Metabolic Panel
Description
Changes in Comprehensive Metabolic Panel
Time Frame
12 weeks
Title
Lipid Panel
Description
Changes in Lipid Panel
Time Frame
12 weeks
Title
Self-reported adverse events
Description
Occurrences of Self-reported adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants who are between 18 - 60 years of age Body mass index values will range from >25.0 to < 32.0 kg/m2, making them qualified as an overweight-to-obese population (https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm) Average body mass index for entire study cohort will be less than 30.0 kg/m2. As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 30.0 kg/m2 Free-living/uninhibited with use of ambulatory assistive devices (e.g. canes, crutches, walkers, etc.) and independent 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 Willingness to maintain consistent sleep duration the evening before study visits Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures Able to complete a peak oxygen consumption exercise test with no contraindications to perform exercise per standards put forth by the American College of Sports Medicine. In other words, they are able to safety complete maximal exercise. Exclusion Criteria: Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals Has liver disease or some form of clinically diagnosed hepatic impairment Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL) Diagnosed with or is being treated for some form of thyroid disease Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year Diagnosed with some form of immune disorder (i.e., HIV/AIDS) History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) Positive medical history for any neurological condition or neurological disease Currently prescribed a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.) Current smoker (average of > 1 pack per day within the past 3 months) has quit within the past six months. This includes all forms of nicotine Intake of any drugs (prescribed or over the counter) or dietary supplements that are known or are purported to weight loss such as thermogenics, hydroxycitric acid, ephedra, capsaicin, etc. Participants who are lactating, pregnant or planning to become pregnant Have a known sensitivity or allergy to any of the study products History of alcohol or substance abuse in the 12 months prior to screening Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study Recent history (<3 months) of exercise training or weight loss (> 5%) Any orthopedic limitation that would prevent participation in a general fitness program 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony M Hagele, MS
Phone
636-949-4785
Email
ahagele@lindenwood.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chad M Kerksick, PhD
Phone
636-627-4629
Email
ckerksick@lindenwood.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad M Kerksick, PhD
Organizational Affiliation
Lindenwood University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise and Performance Nutrition Laboratory
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony M Hagele, MS
Phone
636-949-4785
Email
ahagele@lindenwood.edu
First Name & Middle Initial & Last Name & Degree
Joesi M Krieger, MS
Phone
636-949-4785
Email
jkrieger@lindenwood.edu
First Name & Middle Initial & Last Name & Degree
Chad M Kerksick, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women

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