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

NCT05775003 | Completed

• 1 other identifier: IRB-23-28
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Weight Loss; Body Weight; Cardiometabolic Syndrome

Keywords

weight loss; body composition; cardiometabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Fat Mass (4-Compartment)

  Changes in fat mass using a 4 compartment model

  8 Weeks

Secondary Outcomes (14)

• Lean mass (4-Compartment)

  8 weeks

• Waist circumference

  8 weeks

• Visceral Fat (DEXA)

  8 weeks

• Lean:Fat Ratio (DEXA)

  8 weeks

• Body Mass

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Resistant starch

Dietary Supplement: Exercise

500 mg BAIBA supplementation

EXPERIMENTAL

500 mg BAIBA supplementation

Dietary Supplement: Exercise

500 mg BAIBA supplementation + 40 mg Grains of Paradise

EXPERIMENTAL

500 mg BAIBA supplementation + 40 mg Grains of Paradise

Dietary Supplement: Exercise

Interventions

Exercise DIETARY_SUPPLEMENT

8 week exercise training program - consisting of weight training and cardiovascular exercise

Also known as: Exercise training

500 mg BAIBA supplementation; 500 mg BAIBA supplementation + 40 mg Grains of Paradise; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

Related Publications (7)

• 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.

  PMID: 16046715 BACKGROUND

• 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.

  PMID: 19442301 BACKGROUND

• 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.

  PMID: 21092228 BACKGROUND

• 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.

  PMID: 32156010 BACKGROUND

• 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.

  PMID: 25593845 BACKGROUND

• 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.

  PMID: 23321490 BACKGROUND

• 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.

  PMID: 27237796 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight; Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: April 11, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)