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

NCT02026414 | Completed

• 1 other identifier: 20131230
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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murine study revealed that PrimaVie (PV) significantly changed the expression of genes related to muscle function (unpublished data).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

Obesity

Keywords

PrimaVie; Herbal Supplement; Muscle biopsy; Energy; Exercise; Human skeletal muscle adaptation; Muscle function

Outcome Measures

Primary Outcomes (1)

• Blood plasma assay

  Plasma creatine kinase (U/ml) myoglobin (ng/ml) troponin (ug/L) plasma glucose (mg/dl) lipid profiles (mg/dl) ATP levels (umol/L) Plasma creatine kinase, myoglobin, ATP and troponin will indicate muscle damage (these are "muscle damage markers").

  12 Weeks

Secondary Outcomes (1)

• Muscle Biopsy Results

  12 Weeks

Other Outcomes (1)

• BMI

  12 Weeks

Study Arms (1)

PrimaVie Exercise

EXPERIMENTAL

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.

Dietary Supplement: PrimaVie; Other: Exercise

Interventions

PrimaVie DIETARY_SUPPLEMENT

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.

Also known as: purified and standardized shilajit extract

PrimaVie Exercise

Exercise OTHER

PrimaVie Exercise

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 21-70 years of age
• BMI 25-34.9

You may not qualify if:

• BMI \>35 OR \< 25
• Individuals who are deemed unable to understand the procedures, risks and benefits of the study,( i.e. Informed consent) will be excluded
• Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus); to decrease statistical variability and to minimize potential of confounders.
• History of MRSA (Methicillin-resistant Staphylococcus aureus)
• Steroids (Prednisone, etc.)
• Beta-Blockers
• Immunosuppressants
• Hydrochlorothiazide
• Statins (Crestor, Lipitor, etc.)
• Aspirin
• ACE Inhibitors
• Accutane (within the last 6 months)
• Muscle relaxants and stimulants

Sponsors & Collaborators

• Sanni Raju: lead
• Ohio State University: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center (Davis Heart and Lung Research Institute)

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Das A, Datta S, Rhea B, Sinha M, Veeraragavan M, Gordillo G, Roy S. The Human Skeletal Muscle Transcriptome in Response to Oral Shilajit Supplementation. J Med Food. 2016 Jul;19(7):701-9. doi: 10.1089/jmf.2016.0010.

  PMID: 27414521 DERIVED

Related Links

• Calculating Heart Rate Max
• OSU Wexner Medical Center Comprehensive Wound Center

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gayle Gordillo, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 3, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

US (1)