search
Back to results

Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women (GOP)

Primary Purpose

Obese, Weight Loss, Body Weight

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 Obese focused on measuring weight loss, body composition, 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) or 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

500 mg BAIBA supplementation

500 mg BAIBA supplementation + 40 mg Grains of Paradise

Arm Description

Resistant starch

500 mg BAIBA supplementation

500 mg BAIBA supplementation + 40 mg Grains of Paradise

Outcomes

Primary Outcome Measures

Fat Mass (4-Compartment)
Changes in fat mass using a 4 compartment model

Secondary Outcome Measures

Lean mass (4-Compartment)
changes in lean mass using a 4 compartment model
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. Minimum score is 0. Maximum score is 100. Lower is better.
Energy, focus, attention, and concentration visual analog scales
Changes in Energy, focus, attention, and concentration visual analog scales. Minimum score is 0. Maximum score is 100. Higher is better.
Profile of mood states (POMS)
Changes in Profile of mood states (POMS) Minimum score is 0. Maximum score is 5 for each question. A higher Total Mood Disturbance score is worse, lower is better.
Serum Glycerol
Changes in Serum Glycerol Levels
Fasting glucose
Changes in Fasting glucose
Complete Blood Count
Changes in Complete Blood Count
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
search

1. Study Identification

Unique Protocol Identification Number
NCT05775003
Brief Title
Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women
Acronym
GOP
Official Title
Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women on Changes in Body Composition, Resting Metabolic, and Cardiometabolic Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 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
The goal of this intervention study is to examine changes in body composition, weight loss, and cardio-metabolic risk factors after adding supplementation of L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise to exercise in overweight and obese men and women. Participants will supplement for 8 weeks and complete a 8 week exercise protocol.
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 starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + 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. After hemodynamic assessment, participants will have the first of two resting metabolic rate measurements completed before having a venous blood sample collected for evaluation of health markers (complete blood counts, comprehensive metabolic panels, and lipid panels). Participants will then use an electronic tablet and complete the Profile of Mood States and visual analog scales to evaluate perceptions of energy, focus, attention, hunger, appetite, and concentration. Participants will then be given their daily dose and a timer will be started. From there, participants will have their waist circumference, body water (BIS), and body composition (DEXA) assessed. After completion of these, participants will then wait in the laboratory until an hour has passed and will have a second resting metabolic rate measurement completed. After the second resting metabolic rate measurement, participants will have a second venous blood sample collected to evaluate changes in glycerol. 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 an 8-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 2, 4, and 8 weeks of supplementation. Participants will be asked to follow an 8-10 hour dry fast and to refrain from caffeine, alcohol, nicotine, and exercise (excluding the 30 min daily walk) for 24 hours prior to each study visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Weight Loss, Body Weight, Cardiometabolic Syndrome
Keywords
weight loss, body composition, 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. Eligible study participants will be randomly assigned to one of three supplementation groups: placebo (resistant starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + exercise group.
Masking
ParticipantInvestigator
Masking Description
Eligible study participants will be randomly assigned to one of three supplementation groups: placebo (resistant starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + exercise group.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Resistant starch
Arm Title
500 mg BAIBA supplementation
Arm Type
Experimental
Arm Description
500 mg BAIBA supplementation
Arm Title
500 mg BAIBA supplementation + 40 mg Grains of Paradise
Arm Type
Experimental
Arm Description
500 mg BAIBA supplementation + 40 mg Grains of Paradise
Intervention Type
Dietary Supplement
Intervention Name(s)
Exercise
Other Intervention Name(s)
Exercise training
Intervention Description
8 week exercise training program - consisting of weight training and cardiovascular exercise
Primary Outcome Measure Information:
Title
Fat Mass (4-Compartment)
Description
Changes in fat mass using a 4 compartment model
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Lean mass (4-Compartment)
Description
changes in lean mass using a 4 compartment model
Time Frame
8 weeks
Title
Waist circumference
Description
Changes in waist circumference
Time Frame
8 weeks
Title
Visceral Fat (DEXA)
Description
Changes in Visceral Fat (DEXA)
Time Frame
8 weeks
Title
Lean:Fat Ratio (DEXA)
Description
Changes in Lean:Fat Ratio (DEXA)
Time Frame
8 weeks
Title
Body Mass
Description
Changes in Body Mass
Time Frame
8 weeks
Title
Hunger and appetite visual analog scale
Description
Changes in Hunger and appetite visual analog scale. Minimum score is 0. Maximum score is 100. Lower is better.
Time Frame
8 weeks
Title
Energy, focus, attention, and concentration visual analog scales
Description
Changes in Energy, focus, attention, and concentration visual analog scales. Minimum score is 0. Maximum score is 100. Higher is better.
Time Frame
8 weeks
Title
Profile of mood states (POMS)
Description
Changes in Profile of mood states (POMS) Minimum score is 0. Maximum score is 5 for each question. A higher Total Mood Disturbance score is worse, lower is better.
Time Frame
8 weeks
Title
Serum Glycerol
Description
Changes in Serum Glycerol Levels
Time Frame
8 weeks
Title
Fasting glucose
Description
Changes in Fasting glucose
Time Frame
8 weeks
Title
Complete Blood Count
Description
Changes in Complete Blood Count
Time Frame
8 weeks
Title
Comprehensive Metabolic Panel
Description
Changes in Comprehensive Metabolic Panel
Time Frame
8 weeks
Title
Lipid Panel
Description
Changes in Lipid Panel
Time Frame
8 weeks
Title
Self-reported adverse events
Description
Occurrences of Self-reported adverse events
Time Frame
8 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) or 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
Citations:
PubMed Identifier
23321490
Citation
Wilson JP, Fan B, Shepherd JA. Total and regional body volumes derived from dual-energy X-ray absorptiometry output. J Clin Densitom. 2013 Jul-Sep;16(3):368-373. doi: 10.1016/j.jocd.2012.11.001. Epub 2013 Jan 12.
Results Reference
background
PubMed Identifier
27237796
Citation
Smith-Ryan AE, Mock MG, Ryan ED, Gerstner GR, Trexler ET, Hirsch KR. Validity and reliability of a 4-compartment body composition model using dual energy x-ray absorptiometry-derived body volume. Clin Nutr. 2017 Jun;36(3):825-830. doi: 10.1016/j.clnu.2016.05.006. Epub 2016 May 15.
Results Reference
background
PubMed Identifier
16046715
Citation
Layman DK, Evans E, Baum JI, Seyler J, Erickson DJ, Boileau RA. Dietary protein and exercise have additive effects on body composition during weight loss in adult women. J Nutr. 2005 Aug;135(8):1903-10. doi: 10.1093/jn/135.8.1903.
Results Reference
result
PubMed Identifier
19442301
Citation
Kerksick C, Thomas A, Campbell B, Taylor L, Wilborn C, Marcello B, Roberts M, Pfau E, Grimstvedt M, Opusunju J, Magrans-Courtney T, Rasmussen C, Wilson R, Kreider RB. Effects of a popular exercise and weight loss program on weight loss, body composition, energy expenditure and health in obese women. Nutr Metab (Lond). 2009 May 14;6:23. doi: 10.1186/1743-7075-6-23.
Results Reference
result
PubMed Identifier
21092228
Citation
Kerksick CM, Wismann-Bunn J, Fogt D, Thomas AR, Taylor L, Campbell BI, Wilborn CD, Harvey T, Roberts MD, La Bounty P, Galbreath M, Marcello B, Rasmussen CJ, Kreider RB. Changes in weight loss, body composition and cardiovascular disease risk after altering macronutrient distributions during a regular exercise program in obese women. Nutr J. 2010 Nov 22;9:59. doi: 10.1186/1475-2891-9-59.
Results Reference
result
PubMed Identifier
32156010
Citation
Kerksick CM, Roberts MD, Campbell BI, Galbreath MM, Taylor LW, Wilborn CD, Lee A, Dove J, Bunn JW, Rasmussen CJ, Kreider RB. Differential Impact of Calcium and Vitamin D on Body Composition Changes in Post-Menopausal Women Following a Restricted Energy Diet and Exercise Program. Nutrients. 2020 Mar 7;12(3):713. doi: 10.3390/nu12030713.
Results Reference
result
PubMed Identifier
25593845
Citation
Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.
Results Reference
result

Learn more about this trial

Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women

We'll reach out to this number within 24 hrs