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Dietary Supplements + Exercise for Weight Loss
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have serious heart or stroke issues needing multiple medications.I have had weight loss surgery in the past.I have a gastrointestinal disorder like Colitis or Crohn's.I have severe nerve pain or numbness in my hands or feet.I have type I or II diabetes.I have received two doses of the COVID-19 vaccine.I have muscular dystrophy.I am between 18 and 45 years old.I have severe osteoporosis.I have been diagnosed with a liver condition.I have a history of glaucoma or overactive bladder.I am experiencing changes in my menstrual cycle, am pregnant, planning to become pregnant, or am nursing.I am not taking medications that affect protein metabolism or more than one for lowering blood sugar.My blood pressure is not higher than 140/90 mmHg.I have severe joint pain due to osteoarthritis.I have bone or joint issues.I have lost 10% of my body weight in the last 3 months.I have a lung condition needing more than two medications.My kidney function is normal.I consume less than 10 drinks a week if female, or 15 if male.I am unable to give consent by myself.
- Group 1: Placebo
- Group 2: Muscle5 and TRIM7
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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