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Study was terminated due to the withdrawal of funding, which made it impossible to continue the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (Resistant Dextrin) (n=40) |
|
| 750 mg/day Mitoburn (L-BAIBA) | Experimental | 750 mg/day Mitoburn (L-BAIBA) |
|
| 1,500 mg/day Mitoburn (L-BAIBA) | Experimental | 1,500 mg/day Mitoburn (L-BAIBA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 12 week resistance and cardiovascular exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat Mass (4-compartment) | Changes in Fat Mass (4-compartment) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 4-Compartment Lean mass | Changes in Lean Mass (4-compartment) | 12 weeks |
| Waist circumference | Changes in Waist circumference | 12 weeks |
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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 |
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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.
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Intervention will be blinded to both participant and investigators
| Visceral Fat (DEXA) | Changes in Visceral Fat (DEXA) | 12 weeks |
| Lean:Fat Ratio (DEXA) | Changes in Lean:Fat Ratio (DEXA) | 12 weeks |
| Body Mass | Changes in Body Mass | 12 weeks |
| Hunger and appetite visual analog scale | Changes in Hunger and appetite visual analog scale | 12 weeks |
| Profile of mood states (POMS) | Changes in Profile of mood states (POMS) | 12 weeks |
| Inflammatory markers (e.g. CRP, IL-6, etc.) | Changes in Inflammatory markers (e.g. CRP, IL-6, etc.) | 12 weeks |
| Comprehensive Metabolic Panel | Changes in Comprehensive Metabolic Panel | 12 weeks |
| Lipid Panel | Changes in Lipid Panel | 12 weeks |
| Self-reported adverse events | Occurrences of Self-reported adverse events | 12 weeks |
| 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 |