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临床试验/NCT03854786
NCT03854786终止不适用

A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.

Vedic Lifesciences Pvt. Ltd.2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
2
主要终点
To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals

研究概览

简要总结

Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness.

Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Body Mass Index ≥ 25 - ≤ 34.9 kg/m
  • Waist Circumference ≥ 80 cms.
  • Non-smoker.
  • BP ≤ 140/90 mm Hg
  • FBS ≤ 125 mg/dl
  • Hb ≥ 11 g/ dl
  • Can abstain from strenuous exercise and alcohol for at least 48 hours.
  • Can abstain from caffeine for at least 24 hours.

排除标准

  • Participants with history of regular (≥2 times a week) structured exercise (gym, walking, yoga, etc).
  • Inter-arm blood pressure is ≥10 mm Hg.
  • Known cases of type II Diabetes Mellitus.
  • Known cases of hypertension with or without anti-hypertensive medication.
  • Visual or balance problems, or who cannot walk on a treadmill without using the handrails.

结局指标

主要结局

To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals

时间窗: From baseline to Day 56

Measured by change in VO2 max

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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