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临床试验/NCT04121481
NCT04121481Unknown不适用

Clinical Study on Prodovite® VMP35 Supplement on Athletic Performance

Victory Nutrition International, Inc.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Anthropometric Measurements: Waist-Hip Ratio

研究概览

简要总结

This pilot investigation will conduct a randomized placebo-controlled, double-blind study in 150 volunteers (age: 18-74 years) over a period of 90 consecutive days. A statistician will be involved in this project. Body weight, body mass index (BMI), waist circumference, blood chemistry, blood pressure and heart rate, body and hand grip strength, speed and endurance studies including open circuit spirometry-based assessment of pulmonary function will be assessed. Other parameters to be evaluated include oxygen consumption, CO2 production and metabolic parameters, VO2 max, respiratory exchange ratio (RER), anaerobic threshold, ventilatory equivalents for oxygen (VE/V02) and exhaled carbon dioxide (VE/VC02)2,3. Subjects will participate in completed maximal graded exercise tests (GXT) on a treadmill or in set distance open-field sprints using open-circuit spirometry. Lower and Upper Body Strength will be evaluated. E-Diary will be provided to all participants. Survey Monkey program will be provided to all subjects and regularly updated by all study participants daily and endorsed by the co-Principal Investigator.

详细描述

A novel patented Prodovite® VMP35 Multi-Nutrient-Complex (MNC), a vitamin, mineral, and phytonutrient encapsulated liquid formulation, was prepared using a novel proprietary SK713 SLP multi-lamellar clustoidal non-GMO phospholipid Prodosome nutrient absorption/delivery technology in a state-of-the-art multistep cGMP and NSF-certified manufacturing facility. This developmental technology is biodegradable and biocompatible. Preliminary study in our laboratory demonstrated the efficacy of Prodovite® VMP35 in Sports Nutrition. We hypothesize that Prodovite® VMP35 supplement will enhance athletic performance, lean-body muscle mass, increase exercise tolerance, and improve anabolic parameters in healthy human subjects. The aim of this pilot study is to evaluate the effect of oral supplementation of Prodovite® VMP35 on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that Prodovite® VMP35 supplementation will enhance and increase exercise performance, tolerance, lean-body muscle mass, improve anabolic parameters and blood chemistry parameters in healthy human subjects. Accordingly, 150 healthy male and female subjects will be randomly assigned to receive either Prodovite® VMP35 or placebo in the form of single dose sealed containers for 90 consecutive days and muscle strength, endurance, speed, anabolic/catabolic parameters and muscle mass will be evaluated by dual energy X-ray absorptiometry (DEXA), hand-grip strength test, cycle ergometer test, spirometer assessment and assay of Blood chemistry and serum biomarkers will be evaluated before and after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Double-Blind Placebo-Controlled Study

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Anthropometric Measurements: Waist-Hip Ratio

时间窗: Over a Period of 90-Consecutive Days

Waist : Hip Ratio

Anthropometric Measurements: Body Weight

时间窗: Over a Period of 90-Consecutive Days

Body Weight (Kilograms)

Anthropometric Measurements: Blood Pressure (mmHg)

时间窗: Over a Period of 90-Consecutive Days

Blood Pressure (mmHg)

Body Composition and Bone Mineral Density: DEXA (GE)

时间窗: Over a Period of 90-Consecutive Days

DEXA and Bone Mineral Density

Ergometric Assessment: Treadmill

时间窗: Over a Period of 90-Consecutive Days

Ergometric measurements

Handgrip Dynamometer

时间窗: Over a Period of 90-Consecutive Days

Handgrip strength

Respiration Quality and Rate: Spirometer

时间窗: Over a Period of 90-Consecutive Days

Respiration Quality, VO2 and VCO2 assessments

Endurance Studies

时间窗: Over a Period of 90 Consecutive Days

Cycle Ergometer, Bench Press and Leg Press

Anthropometric Measurements: Waist Circumference

时间窗: Over a Period of 90-Consecutive Days

Waist Circumference (Meters)

Anthropometric Measurements: Height

时间窗: Over a Period of 90-Consecutive Days

Height (Meters)

次要结局

  • Total Blood Chemistry(Over a Period of 90-Consecutive Days)
  • Lipid Profile(Over a Period of 90-Consecutive Days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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