OverweightPhase 3NCT05384431
Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study
A Phase 3 study testing Muscle5 and TRIM7 and Mixed exercise in people with Overweight and Obesity, run by Exerkine Corporation at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Muscle5 and TRIM7 and Mixed exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2022to 20 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 - 45 years
- BMI > 25 kg/m2
- low physical activity level < 150 min/week (< ACSM and CSEP recommendations)
- have had two doses of the COVID-19 vaccine
Who cannot join
- renal disease (creatinine > 140)
- liver disease (i.e. diagnosed NAFLD, NASH, cirrhosis, previous liver transplant)
- GI disorders (i.e. Colitis, Crohns)
- cardiovascular disease (recent myocardial infarction (< 6 months), hypertension requiring more than 2 medications, congestive heart failure requiring more than one medication for control, unstable arrhythmia, angina previous stroke with residual hemiparesis)
- severe osteoarthritis
- significant weight loss in the 3-month period prior to the study (10% of total body weight)
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- muscular dystrophy
- severe peripheral neuropathy
- severe osteoporosis
- uncontrolled hypertension (>140/90 mmHg)
- orthopedic problems
- type I or II diabetes
- respiratory conditions (i.e. chronic pulmonary obstructive disorder), chronic obstructive pulmonary disease (FVC or FEV1 < 70% of age predicted mean value), and asthma requiring more than two medications
- individuals with prior bariatric surgery
- women who have ammenorrhea, dysregulated menstrual cycle, are peri-menopausal, menopausal, pregnant, looking to become pregnant, or nursing
- medications, including anti-inflammatory medications, more than one glucose lowering medication, insulin, platelet inhibitors, anti-coagulant medications, or Simvastatin (zocor), beta-blockers, or weight loss medications (Orlistat, Saxenda Contrave) or any other medications known to affect protein metabolism (i.e.corticosteroids).
- inability to take part in the exercise program
- vegan
- smoking
- history of glaucoma or
- overactive bladder syndrome
- consumption of more than 10 drinks/week or 2 drinks/d for women and 15 drinks/week or 3 drinks/d for men.
- history of allergy, sensitivity or strong dislike towards any component of the study products (supplements)
- have undergone a barium swallow or an infusion of a contrast agent in the past 3 weeks
- have an implantable electronic device
- inability to perform exercise as determined by the Get Active Questionnaire (GAQ)
- inability to consent
- participants on volitional dietary supplements will be considered on a case-by-case basis, but they will be asked to refrain from intake for at least 2 weeks prior to partaking in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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*:
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater loss of bodyweight?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvement in body mass index (BMI)?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvement in waist-to-hip ratio?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater loss of fat mass?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program maintain or improve lean mass?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program maintain or improve lean mass/fat mass ratio (e.g., body composition index)?
Secondary objectives/research questions:
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in muscle strength and aerobic capacity?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in insulin sensitivity?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater reductions in inflammation and greater increases in antioxidant status?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in sleep quality, perceived stress, health-related quality of life and the overall health index?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in hair \& nail growth?
Hypotheses:
- The addition of TRIM 7 and MUSCLE 5 will induce greater 'high-quality' weight loss than exercise alone as evidenced by A) greater loss of fat mass, B) greater gain (or maintenance) of lean mass, C) greater improvement in lean mass/fat mass ratio (e.g., body composition index) D) greater loss of bodyweight E) greater reduction in waist-to-hip ratio and/or F) greater improvement in BMI.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in muscle strength and aerobic fitness than exercise alone as evidenced by a greater improvement in 1RM and VO2peak than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in insulin sensitivity (HOMA-IR, glycemic control during an OGTT, Matsuda Index) than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce a greater reduction in inflammation (TNFα, IL6, CRP, IL- 10) and induce a greater improvement in antioxidant status (GSH:GSSG, CuZn SOD, MnSOD, catalase, total reducing capacity of plasma) than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in sleep quality, perceived stress, health-related quality of life, and an overall health index than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in hair \& nail growth than exercise alone.
- Conditions
- Overweight, Obesity
- Being tested
- Muscle5 and TRIM7, Mixed exercise
- Keywords
- Overweight, Obesity, Exercise, Supplementation, Aerobic training, Resistance training, Insulin sensitivity, Sex differences, Inflammation, Oxidative stress, Weight management, Antioxidants, Protein
- Medical subject headings
- Overweight, Obesity, Motor Activity, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle5 and TRIM7Dietary supplement
Intake of MUSCLE 5 and TRIM 7 supplements on a daily basis for 12 weeks
Mixed exerciseOther
Mixed exercise (aerobic and resistance) three days per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Muscle5 and TRIM7; Other: Mixed exercise |
| 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 Receives: Other: Mixed exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bodyweight change
scale
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
BMI change
Body mass index (weight/height squared)
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Fat mass change
body composition by DEXA
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Lean mass change
body composition by DEXA
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Lean mass/fat mass (body composition index) change
body composition by DEXA
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Percent body fat change
body composition by DEXA
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Waist-to-hip ratio change
measure tape
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Secondary outcomes (12)
VO2max change
Maximal aerobic capacity test (gas exchange and indirect calorimetry measured using a metabolic cart and incremental cycle ergometry)
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Lower body strength change
1-repetition and 5-repetition maximal strength
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Upper body strength change
1-repitition maximal strength and 5-repeitition maximal strength
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Appendicular lean mass change
body composition by DEXA
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Insulin sensitivity change
Oral glucose tolerance test (OGTT)
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Blood lipids change
cholesterol (LDL, HDL, and total cholesterol) and triglycerides
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation CRP change
pro-inflammatory circulatory factor (ng/mL) by Luminex Performance Assay
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation TNF-alpha change
pro inflammatory circulatory factor (pg/ml) by Luminex Performance Assay
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-1 change
pro inflammatory circulatory factor (pg/ml) by Luminex Performance Assay
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-10 change
anti-inflammatory circulatory factors (pg/mL) by Luminex Performance Assay
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-6 change
pro-inflammatory circulatory factor (pg/mL) by Luminex Performance Assay
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Antioxidant capacity change
TEAC (trolox equivalent antioxidant assay)
Measured: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start15 Aug 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo controlled, parallel group design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exerkine Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- Michaela Devries-Aboud, PhD, Principal investigator, Kinesiology and Health Sciences, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384431
- Sponsor's protocol ID
- 43396
- Status last verified
- Jan 2025
- First submitted
- 10 May 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can We Achieve 'high-quality' Weight Loss Through Supplementation and Exercise? the TRIM MUSCLE Study
- ClinicalTrials.gov ID
- NCT05384431
- Acronym / sponsor ID
- 43396
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Exercise, Supplementation, Aerobic training, Resistance training, Insulin sensitivity, Sex differences
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Exerkine CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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*:
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater loss of bodyweight?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvement in body mass index (BMI)?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvement in waist-to-hip ratio?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater loss of fat mass?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program maintain or improve lean mass?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program maintain or improve lean mass/fat mass ratio (e.g., body composition index)?
Secondary objectives/research questions:
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in muscle strength and aerobic capacity?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in insulin sensitivity?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater reductions in inflammation and greater increases in antioxidant status?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in sleep quality, perceived stress, health-related quality of life and the overall health index?
- Can the addition of TRIM 7 and MUSCLE 5 to an exercise program induce greater improvements in hair \& nail growth?
Hypotheses:
- The addition of TRIM 7 and MUSCLE 5 will induce greater 'high-quality' weight loss than exercise alone as evidenced by A) greater loss of fat mass, B) greater gain (or maintenance) of lean mass, C) greater improvement in lean mass/fat mass ratio (e.g., body composition index) D) greater loss of bodyweight E) greater reduction in waist-to-hip ratio and/or F) greater improvement in BMI.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in muscle strength and aerobic fitness than exercise alone as evidenced by a greater improvement in 1RM and VO2peak than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in insulin sensitivity (HOMA-IR, glycemic control during an OGTT, Matsuda Index) than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce a greater reduction in inflammation (TNFα, IL6, CRP, IL- 10) and induce a greater improvement in antioxidant status (GSH:GSSG, CuZn SOD, MnSOD, catalase, total reducing capacity of plasma) than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in sleep quality, perceived stress, health-related quality of life, and an overall health index than exercise alone.
- The addition of TRIM 7 and MUSCLE 5 will induce greater improvements in hair \& nail growth than exercise alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, parallel group design.
| Arm | Type | Receives |
|---|---|---|
| Muscle5 and TRIM7 | Active comparator | Dietary Supplement: Muscle5 and TRIM7, Other: Mixed exerciseMUSCLE5 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 | Other: Mixed exercisePlacebo 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18 - 45 years
- BMI > 25 kg/m2
- low physical activity level < 150 min/week (< ACSM and CSEP recommendations)
- have had two doses of the COVID-19 vaccine
Key exclusion criteria (28 listed)
- renal disease (creatinine > 140)
- liver disease (i.e. diagnosed NAFLD, NASH, cirrhosis, previous liver transplant)
- GI disorders (i.e. Colitis, Crohns)
- cardiovascular disease (recent myocardial infarction (< 6 months), hypertension requiring more than 2 medications, congestive heart failure requiring more than one medication for control, unstable arrhythmia, angina previous stroke with residual hemiparesis)
- severe osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle5 and TRIM7Intake of MUSCLE 5 and TRIM 7 supplements on a daily basis for 12 weeks | Dietary supplement | Muscle5 and TRIM7 |
| Mixed exerciseMixed exercise (aerobic and resistance) three days per week for 12 weeks | Other | Muscle5 and TRIM7, Placebo |
Primary outcome
Bodyweight change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
scale
BMI change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Body mass index (weight/height squared)
Fat mass change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
body composition by DEXA
Lean mass change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
body composition by DEXA
Lean mass/fat mass (body composition index) change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
body composition by DEXA
Percent body fat change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
body composition by DEXA
Waist-to-hip ratio change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
measure tape
12 secondary outcomes
VO2max change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Lower body strength change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Upper body strength change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Appendicular lean mass change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Insulin sensitivity change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Blood lipids change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation CRP change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation TNF-alpha change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-1 change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-10 change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Inflammation IL-6 change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Antioxidant capacity change
Time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Devries-Aboud, PhD principal investigator
Kinesiology and Health Sciences, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Muscle5 and TRIM7 and Mixed exercise in people with Overweight and Obesity, run by Exerkine Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bodyweight change (time frame: baseline 0 weeks ("pre study") to 12 weeks ("post study")). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.