What side effects are associated with this type of intervention?

Common treatments for obesity that include protein, creatine, vitamins, and various extracts can have side effects. Protein supplements may cause digestive issues like bloating and gas. Creatine can lead to water retention and, rarely, kidney issues. Excessive vitamin intake can result in toxicity, causing symptoms like nausea and headaches. Extracts such as caffeine, green tea, and forskolin can boost metabolism but may cause jitteriness, increased heart rate, and digestive discomfort. Monitoring for adverse reactions is important when combining these supplements with exercise.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, focusing on mechanisms such as appetite suppression, fat absorption inhibition, and metabolic enhancement. Notable examples include orlistat, which inhibits fat absorption, and phentermine-topiramate, which suppresses appetite. While these drugs do not directly align with the combination of protein, creatine, vitamins, and extracts studied in the MUSCLE 5 and TRIM 7 trial, they share the common goal of promoting weight loss and improving overall health. Additionally, newer treatments like liraglutide and semaglutide, which are GLP-1 receptor agonists, have shown efficacy in weight management by enhancing satiety and reducing food intake.

What other types of research exist?

Promising alternatives to MUSCLE 5 and TRIM 7 for obesity patients include a combination of L-carnitine tartrate and creatine monohydrate, as well as eicosapentaenoic acid (EPA) from fish oil. These supplements have shown potential in enhancing muscle protein synthesis, improving lean body mass, and overall health.

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Other

Dietary Supplements + Exercise for Weight Loss

Q: What is the mechanism of action of this treatment?

Common treatments for obesity, such as those studied in the MUSCLE 5 and TRIM 7 supplements, work through various mechanisms to enhance muscle building, fat loss, and overall health. Protein supports muscle growth and repair, which can increase metabolic rate and aid in fat loss. Creatine enhances muscle strength and performance, allowing for more effective workouts. Vitamins like D and E play roles in metabolic processes and antioxidant protection, improving overall health. Extracts such as green tea and green coffee bean boost metabolism and fat oxidation, while compounds like forskolin and coenzyme Q10 support energy production and reduce inflammation. These mechanisms are crucial for obesity patients as they not only promote weight loss but also improve muscle mass, metabolic health, and reduce the risk of obesity-related complications.

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

Must not have

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)

Individuals with prior bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study")

Awards & highlights

Pivotal Trial

Summary

This trial tests whether taking two dietary supplements along with regular exercise can help overweight and obese people lose weight and improve their health more effectively than just exercising alone.

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.

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.

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

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I have received two doses of the COVID-19 vaccine.

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart or stroke issues needing multiple medications.

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I have had weight loss surgery in the past.

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I have a gastrointestinal disorder like Colitis or Crohn's.

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I have severe nerve pain or numbness in my hands or feet.

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I have type I or II diabetes.

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I have muscular dystrophy.

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I have severe osteoporosis.

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I have been diagnosed with a liver condition.

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I have a history of glaucoma or overactive bladder.

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My blood pressure is not higher than 140/90 mmHg.

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I have severe joint pain due to osteoarthritis.

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I have lost 10% of my body weight in the last 3 months.

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I have a lung condition needing more than two medications.

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My kidney function is normal.

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I consume less than 10 drinks a week if female, or 15 if male.

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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline 0 weeks ("pre study"), 6 weeks ("midway"), and 12 weeks ("post study")

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BMI change

Bodyweight change

Fat mass change

+4 more

Secondary study objectives

Antioxidant capacity change

Appendicular lean mass change

Lipids

+9 more

Other study objectives

Female hair growth & quality (WHGQ)

Health-related quality of life (SF 36)

Male hair growth & quality (Merk & Co, 1996)

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as those studied in the MUSCLE 5 and TRIM 7 supplements, work through various mechanisms to enhance muscle building, fat loss, and overall health. Protein supports muscle growth and repair, which can increase metabolic rate and aid in fat loss. Creatine enhances muscle strength and performance, allowing for more effective workouts. Vitamins like D and E play roles in metabolic processes and antioxidant protection, improving overall health. Extracts such as green tea and green coffee bean boost metabolism and fat oxidation, while compounds like forskolin and coenzyme Q10 support energy production and reduce inflammation. These mechanisms are crucial for obesity patients as they not only promote weight loss but also improve muscle mass, metabolic health, and reduce the risk of obesity-related complications.

Magnetic fields modulate metabolism and gut microbiome in correlation with Pgc-1α expression: Follow-up to an in vitro magnetic mitohormetic study.Insulin resistance and sarcopenia: mechanistic links between common co-morbidities.Febuxostat improves outcome in a rat model of cancer cachexia.