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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Resistant starch |
|
| 500 mg BAIBA supplementation | Experimental | 500 mg BAIBA supplementation |
|
| 500 mg BAIBA supplementation + 40 mg Grains of Paradise | Experimental | 500 mg BAIBA supplementation + 40 mg Grains of Paradise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Dietary Supplement | 8 week exercise training program - consisting of weight training and cardiovascular exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat Mass (4-Compartment) | Changes in fat mass using a 4 compartment model | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lean mass (4-Compartment) | changes in lean mass using a 4 compartment model | 8 weeks |
| Waist circumference | Changes in waist circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad M Kerksick, PhD | Lindenwood University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise and Performance Nutrition Laboratory | Saint Charles | Missouri | 63301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23321490 | 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. | |
| 27237796 | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001835 | Body Weight |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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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.
|
| 8 weeks |
| Visceral Fat (DEXA) | Changes in Visceral Fat (DEXA) | 8 weeks |
| Lean:Fat Ratio (DEXA) | Changes in Lean:Fat Ratio (DEXA) | 8 weeks |
| Body Mass | Changes in Body Mass | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| Serum Glycerol | Changes in Serum Glycerol Levels | 8 weeks |
| Fasting glucose | Changes in Fasting glucose | 8 weeks |
| Complete Blood Count | Changes in Complete Blood Count | 8 weeks |
| Comprehensive Metabolic Panel | Changes in Comprehensive Metabolic Panel | 8 weeks |
| Lipid Panel | Changes in Lipid Panel | 8 weeks |
| Self-reported adverse events | Occurrences of Self-reported adverse events | 8 weeks |
| 16046715 | Result | 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. |
| 19442301 | Result | 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. |
| 21092228 | Result | 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. |
| 32156010 | Result | 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. |
| 25593845 | Result | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |