Effects of PrimaVie and Exercise Training on Human Skeletal Muscle Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Blood plasma assay
研究概览
简要总结
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murine study revealed that PrimaVie (PV) significantly changed the expression of genes related to muscle function (unpublished data).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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 21-70 years of age
- •BMI 25-34.9
排除标准
- •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.
- •Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable. Pregnant women are excluded 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)
- •Current use of any of the following medications will result in exclusion:
- •Steroids (Prednisone, etc.)
- •Beta-Blockers
- •Immunosuppressants
- •Hydrochlorothiazide
- •Statins (Crestor, Lipitor, etc.)
- •ACE Inhibitors
- •Accutane (within the last 6 months)
- •Muscle relaxants and stimulants
结局指标
主要结局
Blood plasma assay
时间窗: 12 Weeks
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").
次要结局
- Muscle Biopsy Results(12 Weeks)
研究者
Sanni Raju
CEO
Natreon, Inc.