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Effects of PrimaVie and Exercise Training on Human Skeletal Muscle (PrimaVie)

NCT02026414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-07-01

No results posted yet for this study

Summary

PrimaVie (Natreon Inc), is a a purified and standardized shilajit extract for nutraceutical use. Research indicates that PrimaVie® has targeted action for increasing energy, revitalization and anti-aging. Findings on a recent murine study revealed that PrimaVie (PV) significantly changed the expression of genes related to muscle function (unpublished data). Based on these facts, it was thought of interest to study the effect of PrimaVie and exercise training on human skeletal muscle adaptation.

The objective of the study is to determine effect of PrimaVie supplementation and combined PrimaVie supplementation and exercise on changes in muscle gene expression related to muscle function. Two hypothesizes have been made, oral supplementation of PrimaVie twice a day for 12 weeks will influence gene expression in the skeletal muscle of pre-obese to obese humans, oral supplementation of PV will act with treadmill exercise training to favorably impact skeletal muscle gene expression. The participants will have a total of 3 visits over 12 weeks. During each visit will include measurement of height, weight and vital signs, 2 tablespoons of blood will be draw from left or right arm, and muscle biopsies (using biopsy needle) will be collected under the use of local anesthetics. The blood and muscle biopsies will be used for all lab related procedure.

Conditions

Interventions

DIETARY_SUPPLEMENT

PrimaVie

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.

OTHER

Exercise

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • Sanni Raju

    lead INDUSTRY

Principal Investigators

  • Gayle Gordillo, MD · Ohio State University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02026414 on ClinicalTrials.gov