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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
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The purpose of this study is to determine whether the combination of two dietary supplements: MUSCLE 5, which contains protein, creatine and vitamin D and TRIM 7, which contains beet extract, caffeine, coenzyme Q10, alpha lipoic acid, forskolin extract, green coffee bean extract, green tea and vitamin E, plus exercise can induce greater 'high-quality' weight loss than exercise alone in overweight and obese men and women. First, the investigators will examine whether the addition of these two supplements to a mixed exercise regime (e.g., aerobic and resistance training) induces greater improvements in typical training adaptations (aerobic capacity, upper & lower body muscle strength, lean mass, ASM, fat mass, % body fat, and lean mass/fat mass). Secondly, the investigators will assess improvements in pro- and anti-inflammatory factors, insulin sensitivity, and blood lipids. Third, the investigators will determine effects on perceived stress, sleep quality, hair & nail growth, and health-related quality of life. Overweight men and women will be randomized to either exercise alone or exercise plus supplement for 12 weeks. Training will include mixed exercise (aerobic and resistance) three days per week and supplements will be taken on a daily basis. Before and after the 12-week training period the investigators will assess A) Body weight, BMI, DXA outcomes (total lean mass, total body fat, % body fat, ASM, and lean mass/fat mass), waist circumference, VO2max, and upper/lower body maximal strength, B) Circulatory inflammatory factors, antioxidants, blood lipids, and oral glucose tolerance/insulin sensitivity (OGTT), C) Perceived stress, sleep quality, hair & nail growth, and health-related quality of life and D) Overall Health Index. Benefits of the study to participants may include weight loss and improved health (irrespective of weight loss). Benefits of the study to the scientific community include improved understanding of how high-quality protein- and antioxidant-containing supplements, combined with mixed exercise, affect weight loss and overall health in men and women. Thus, the investigators will be comparing men and women to determine if the response to supplementation and exercise is similar or different between the sexes.
The purpose of the proposed study is to determine if the addition of two supplements (TRIM 7 and MUSCLE 5) to an exercise regime can induce more favorable effects on body weight, BMI, body composition (lean mass, fat mass, % body fat, ASM, and lean mass/fat mass), upper & lower body strength, aerobic fitness (VO2max), insulin sensitivity (OGTT), blood lipids (cholesterol and triglycerides), antioxidant capacity (total reducing capacity of plasma), inflammation (TNFα, IL6, CRP, IL- 10) and overall health in overweight men and women.
Primary objective/research question*:
-Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater 'high-quality' weight loss?
Co-primary objectives/research questions*:
Secondary objectives/research questions:
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscle5 and TRIM7 | Active Comparator | MUSCLE5 and TRIM7 natural health product supplementation Name of natural health product (brand name, generic) - MUSCLE 5, chocolate Is this a market-approved natural health product (per Health Canada)? - Yes Dose - 1 scoop Ingredients (per dose) - Whey protein isolate (24g), milk protein isolate (16g), Creatine (3g), Calcium (450mg), Vitamin D (1000 IU) Frequency of administration - Once/day Duration (e.g., six weeks) - 12 weeks Route of administration - Oral Name of natural health product (brand name, generic) - TRIM7 Is this a market-approved natural health product (as per Health Canada)? Yes Dose - 3 capsules Ingredients (per dose) - Alpha lipoic acid (200mg), CoEnzyme Q10 (100mg), beet root extract (250mg), green coffee bean extract (250mg), green tea extract (250mg), forskolin (25mg), Vitamin E (22 mg AT) Frequency of administration - Twice/day Duration (e.g., six weeks) - 12 weeks Route of administration - Oral |
|
| Placebo | Placebo Comparator | Placebo collagen and microcrystalline cellulose intake Placebo Control 1 (Counter to MUSCLE5) Dose - 1 scoop Ingredients (per dose) - Collagen (40g) Frequency of administration - once/day Duration - 12 weeks Route of administration - Oral Placebo Control 2 (Counter to TRIM7) Dose - 3 capsules Ingredients (per dose) - Microcrystalline cellulose (400 mg) Frequency of administration - twice/day Duration - 12 weeks Route of administration - Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle5 and TRIM7 | Dietary Supplement | Intake of MUSCLE 5 and TRIM 7 supplements on a daily basis for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bodyweight change | scale | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| BMI change | Body mass index (weight/height squared) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Fat mass change | body composition by DEXA | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Lean mass change | body composition by DEXA | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Lean mass/fat mass (body composition index) change | body composition by DEXA | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Percent body fat change | body composition by DEXA | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Waist-to-hip ratio change | measure tape | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Measure | Description | Time Frame |
|---|---|---|
| VO2max change | Maximal aerobic capacity test (gas exchange and indirect calorimetry measured using a metabolic cart and incremental cycle ergometry) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Lower body strength change |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress change (Perceived Stress Scale) | Perceived Stress Scale (PSS-10; 0 = lowest stress, 40 = highest stress) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Sleep quality change (Bergen Insomnia Scale) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michaela Devries-Aboud, PhD | Kinesiology and Health Sciences, University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michaela Devries-Aboud | Waterloo | Ontario | N2L3G1 | Canada |
There are no plans of making the clinical trial data at the individual level available to researchers who were not part of the original study team
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Randomized, placebo controlled, parallel group design.
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All Exerkine and University of Waterloo research staff will be blinded to the study.
| Mixed exercise | Other | Mixed exercise (aerobic and resistance) three days per week for 12 weeks |
|
1-repetition and 5-repetition maximal strength
| baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Upper body strength change | 1-repitition maximal strength and 5-repeitition maximal strength | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Appendicular lean mass change | body composition by DEXA | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Insulin sensitivity change | Oral glucose tolerance test (OGTT) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Blood lipids change | cholesterol (LDL, HDL, and total cholesterol) and triglycerides | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Inflammation CRP change | pro-inflammatory circulatory factor (ng/mL) by Luminex Performance Assay | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Inflammation TNF-alpha change | pro inflammatory circulatory factor (pg/ml) by Luminex Performance Assay | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Inflammation IL-1 change | pro inflammatory circulatory factor (pg/ml) by Luminex Performance Assay | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Inflammation IL-10 change | anti-inflammatory circulatory factors (pg/mL) by Luminex Performance Assay | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Inflammation IL-6 change | pro-inflammatory circulatory factor (pg/mL) by Luminex Performance Assay | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Antioxidant capacity change | TEAC (trolox equivalent antioxidant assay) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
Bergen Insomnia Scale (0 = lowest insomnia, 42 = highest insomnia)
| baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Health-related quality of life (SF 36) | 36 Item Short Form Survey (SF 36; 0 = maximal disability, 100 = no disability) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Male hair growth & quality (Merk & Co, 1996) | 5 item survey (Merk & Co; 38 = maximal score (highest quality), 5 = lowest score (lowest quality)) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Female hair growth & quality (WHGQ) | 4 item survey (WHGQ; 28 = maximal score (highest quality), 4 = lowest score (lowest quality)) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Nail health | 5 item survey (25 = maximal score, 5 = lowest score) | baseline 0 weeks ("pre study") to 12 weeks ("post study") |
| Nail growth change | Ten-day nail growth will be measured by a digital caliper (Mitotoyu 500) three times during the course of the study (baseline, midway, and post). | baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study") |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |