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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 21-70 years of age
BMI 25-34.9
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is to study the effect of the nutraceutical PrimaVie and exercise on human skeletal muscle adaptation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood plasma assay
Secondary outcome measures
Muscle Biopsy Results
Other outcome measures
BMI
Trial Design
1Treatment groups
Experimental Treatment
Group I: PrimaVie ExerciseExperimental Treatment2 Interventions
Subjects will take 250 mg of PrimaVie (herbal supplement manufactured by Natreon, Inc) twice a day for the first 8 weeks they are enrolled in the study. For the last 4 weeks of the study, subjects will take 250 mg of PrimaVie (herbal supplement manufactured by Natreon, Inc) supplement twice a day while also completing supervised exercise on a treadmill (70-75% of maximum Heart Rate for 20 mins, plus 5 minutes of warm up and 5 minutes of cool down exercises for a total of 30 minutes a day 3 days a week). Subjects will participate for a total of 12 weeks and come for three total visits. At each visit, subjects will have muscle biopsies taken from their thigh or calf as well as approximately 2 tablespoons of blood drawn.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PrimaVie
2014
N/A
~30
Find a Location
Who is running the clinical trial?
Ohio State UniversityOTHER
823 Previous Clinical Trials
501,174 Total Patients Enrolled
23 Trials studying Obesity
4,012 Patients Enrolled for Obesity
Sanni RajuLead Sponsor
Gayle Gordillo, MDPrincipal InvestigatorOhio State University
6 Previous Clinical Trials
1,596 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
The Ohio State University Wexner Medical Center (Davis Heart and Lung Research Institute)
What portion of applicants met pre-screening criteria?
Met criteria
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