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Dietary Supplements + Exercise for Weight Loss

Phase 3
Recruiting
Led By Michaela Devries-Aboud, PhD
Research Sponsored by Exerkine Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have had two doses of the COVID-19 vaccine
Age 18 - 45 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study")
Awards & highlights

Study Summary

This trial is testing whether a combination of two dietary supplements and exercise can help people lose more weight than exercise alone. The study will also look at whether this combination can improve participants' overall health.

Who is the study for?
This trial is for men and women aged 18-45 with a BMI over 25 who are not very active, have had two COVID-19 vaccine doses, and don't have certain health conditions like severe osteoporosis or uncontrolled hypertension. It's not for those with GI disorders, muscular dystrophy, liver disease, cardiovascular issues, diabetes, orthopedic problems, respiratory conditions or those on specific medications.Check my eligibility
What is being tested?
The TRIM MUSCLE Study tests if the supplements Muscle5 (protein mix) and TRIM7 (antioxidants & stimulants), combined with mixed exercise (aerobic and resistance training), lead to better weight loss quality than exercise alone in overweight individuals. The study also looks at how these affect inflammation levels, insulin sensitivity, stress perception and overall health.See study design
What are the potential side effects?
Potential side effects from the supplements may include digestive discomfort due to beet extract or caffeine-related symptoms such as jitteriness or increased heart rate. Exercise can cause muscle soreness or fatigue. Individual reactions to the supplement ingredients will vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received two doses of the COVID-19 vaccine.
Select...
I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study")
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study") for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI change
Bodyweight change
Fat mass change
+4 more
Secondary outcome measures
Antioxidant capacity change
Appendicular lean mass change
Lipids
+9 more
Other outcome measures
Female hair growth & quality (WHGQ)
Health-related quality of life (SF 36)
Male hair growth & quality (Merk & Co, 1996)
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Muscle5 and TRIM7Active Control2 Interventions
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
Group II: PlaceboPlacebo Group1 Intervention
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

Find a Location

Who is running the clinical trial?

Exerkine CorporationLead Sponsor
University of WaterlooOTHER
123 Previous Clinical Trials
209,721 Total Patients Enrolled
3 Trials studying Obesity
1,602 Patients Enrolled for Obesity
Michaela Devries-Aboud, PhDPrincipal InvestigatorKinesiology and Health Sciences, University of Waterloo

Media Library

Mixed exercise (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05384431 — Phase 3
Obesity Research Study Groups: Placebo, Muscle5 and TRIM7
Obesity Clinical Trial 2023: Mixed exercise Highlights & Side Effects. Trial Name: NCT05384431 — Phase 3
Mixed exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384431 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any inclusion/exclusion criteria for participants in this research?

"This study is currently enrolling 60 patients that between the ages of 18-45 and are considered overweight. Other requirements for potential participants include: age 18 - 45 years, BMI > 25 kg/m2, sedentary (less than one exercise session per week), have had two doses of the COVID-19 vaccine."

Answered by AI

Does this experimental research include adults in their twenties or older?

"The age limit to enroll in this study is 18-45. There are 229 medical trials for people younger than 18 and 796 for people older than 65."

Answered by AI

Have either of the drugs Muscle5 or TRIM7 received FDA approval?

"There is some clinical data to support the efficacy of Muscle5 and TRIM7, so it received a safety score of 3."

Answered by AI

What are the specific goals of this experiment?

"The primary metric by which success will be judged in this medical study is change in lean mass over the course of 12 weeks. Additional measures of success include change in lower body strength, antioxidant capacity, and inflammation."

Answered by AI

Are volunteers needed for this clinical research?

"The study, as indicated by information available on clinicaltrials.gov, is recruiting patients. The listing for the trial was first posted on August 15th, 2020 and was most recently updated on September 27th, 2020."

Answered by AI
~23 spots leftby Mar 2025