Effects of PrimaVie and Exercise Training on Human Skeletal Muscle (PrimaVie)
Condition: Obesity
Study type: Interventional

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      significantly changed the expression of genes related to muscle function (unpublished data).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.
    

Detailed description: 
      Potential subjects will see an advertisement placed in locations around the Wexner Medical
      Center with RN (research nurse) listed as the main contact. After potential subjects contact
      the research nurse, he/she will use inclusion/exclusion criteria to determine potential
      eligibility. If the potential subject meets all inclusion/exclusion criteria, he/she will be
      scheduled for a primary visit at the Morehouse Medical Plaza or Davis Heart and Lung Research
      Institute. At this initial visit, the research nurse will meet the potential subject in a
      private room where the study will be fully explained in lay language, and informed consent
      will be obtained. Then, appropriate demographic, biometric and health/clinical information
      will be recorded on the data collection sheet, and 22.5 mL of blood will be obtained via
      venipuncture in the right/ left forearm. A muscle biopsy will also be collected by a trained
      physician. The blood and muscle biopsy will be used for all lab related study procedures. The
      subjects will be given an 8-week supply of the PrimaVie supplement with instructions, as well
      as a copy of the research protocol and informed consent form. If the supplements are mailed,
      they will also have instructions, as well as a copy of the research protocol and informed
      consent form mailed. The subject will be instructed to call the Research Nurse/ approved
      study personnel to let them know that they have received the supplements by mail and to go
      over any questions or concerns the subject may have as well as to schedule follow up visits.
      All follow up visits (T1, T2, T3a and T3b) will consist of a 22.5 mL blood draw, collection
      of muscle biopsy/biopsies and measurement of previously specified demographic, biometric and
      health/clinical variables.

      For 4 weeks of exercise treadmill training (70-75% HRmax for 20 mins; 5 min warm up and 5 min
      cool down - total 30 mins a day; 3 days a week), the subjects will be doing supervised (study
      personnel) exercise routine (Treadmill) at study designated facilities( located on The Ohio
      State University campus).

      Study Hypotheses:

        -  Hypothesis 1: That oral supplementation of PrimaVie twice a day for 12 weeks will
           influence gene expression in the skeletal muscle of sedentary pre-obese to obese humans

        -  Hypothesis 2: That oral supplementation of PrimaVie will synergistically act with
           treadmill exercise training to favorably impact skeletal muscle gene expression.

      Aim: A non-randomized, longitudinal study to determine the effect of PrimaVie and exercise
      training on human skeletal muscle adaptation in 30 pre-obese to obese volunteers.

      Participants: 40 volunteers will be recruited via study advertisement, and contact the
      research staff based on the study inclusion and exclusion criteria. At each visit the
      following will be recorded/collected:

        -  22.5 mL of blood (approximately 2 tablespoons) (venipuncture)

        -  Muscle biopsy/biopsies (1 muscle biopsy per visit collected at T1 and T2, and 2 muscle
           biopsies are collected at T3)

        -  Age (years)

        -  Sex (M/F)

        -  Height (cm)

        -  Weight (lbs)

        -  BMI (Kg/m2)

        -  Blood pressure (mm/Hg)

        -  Pulse

        -  Body fat Percentage

        -  During the first visit (enrollment visit, T1), the following information will be
           recorded/collected as well:

        -  Tobacco use history

        -  Current alcohol use

        -  Current other drug use

        -  Current exercise regimen

        -  Date of first day of last menstrual period (for females only)

        -  Current Medications

        -  Allergies

        -  Nonmedical information, including: address (will be used to send PrimaVie supplement via
           mail, when applicable); telephone number, and email address

      Participants will come for three visits:

        -  Visit 1 (T1) - Baseline (prior to the start of supplementation)

        -  Visit 2 (T2) - First 8 weeks of supplementation alone

        -  Visit 3 (T3) - Next 4 weeks of supplementation together with exercise (T3 consists of 2
           sample collections: T3a (pre-exercise) after 12 weeks of supplementation together with 4
           weeks of exercise - samples taken immediately before the final exercise routine (during
           Visit 3), and T3b (post exercise) after 12 weeks of supplementation together with 4
           weeks of exercise immediately after the final exercise routine (during Visit 3)

      Samples collected from participants:

        -  Peripheral blood: At all visits, 22.5 mL of peripheral venous blood will be collected.

        -  Muscle biopsies: biopsies will be collected from the Vastus lateralis or Gastrocnemius
           muscles. A biopsy will be collected by a board certified Physician after application of
           local anesthetic to the site of biopsy.

      Study Supplement: 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. PrimaVie® also works at the cellular level, playing a
      direct role in the synthesis of ATP, a compound that supplies the body with energy, and
      healthy mitochondrial function. 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. Participants will take:

        -  500 mg/day PrimaVie (Natreon Inc.) supplement, 250 twice a day for the first 8 weeks of
           the study( a 250 mg capsule in the morning with food and a 250 mg capsule in the evening
           with food)

        -  500 mg/day PrimaVie (Natreon Inc) supplement, 250 mg twice a day for the next 4 weeks (a
           250 mg capsule in the morning with food and a 250 mg capsule in the evening with food)
           of the study while including supervised exercise treadmill training, which includes:

        -  exercise supervised treadmill training (supervised treadmill training which include a 5
           minute warm up; 70-75% HRmax for 20 minutes; and a 5 minute cool down - a total 30
           minutes per day for 3 days per week)
    

Intervention name(s): PrimaVie; Exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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 intervention name(s): purified and standardized shilajit extract
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: PrimaVie; Herbal Supplement; Muscle biopsy; Energy; Exercise; Human skeletal muscle adaptation; Muscle function