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临床试验/NCT03686982
NCT03686982已完成不适用

The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance

PepsiCo Global R&D1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Mean power output during intermittent exercise test

研究概览

简要总结

Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is designed to assess the efficacy of a newly developed product containing a mixture of these compounds. Specifically, the study will assess if the product is capable of increasing NO bioavailability and if this results in positive effects on exercise economy and intermittent exercise performance. These outcome measures have been chosen because they have previously been positively impacted by an increase in NO bioavailability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female participants in self-reported good general health as assessed by the standard procedures described below and specifically meeting the following blood pressure (BP) and body mass index (BMI) ranges: systolic BP: 100-140 mmHg; diastolic BP: 60-90 mmHg; and BMI 18.5-
  • 18-40 years of age
  • Physically active. Determined by meeting the following criteria: completes vigorous physical activity (i.e. activities that take hard physical effort and make you breathe much harder than normal; e.g. heavy lifting, digging, aerobics, fast cycling, running etc) at least 2 x per week and moderate physical activities (i.e. activities that take moderate physical effort and make you breath somewhat harder than normal; for example: carrying light loads, cycling at a regular pace, playing doubles tennis) at least 3 x per week.
  • Understanding of the procedures to be undertaken as part of the study
  • Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
  • Informed, voluntary, written consent to participate in the study

排除标准

  • Known pulmonary, cardiovascular or metabolic disease
  • Food allergies including phenylketonurea (PKU)
  • Current regular use of any dietary supplement (excluding macronutrient based supplements) or previous use of any dietary supplement in the past 6 months that is known to have a lasting effect.
  • Blood donation within 3 months prior to the start of the study
  • Substance abuse within 2 years of the start of the study
  • Any prescription and non-prescription medication which may impact saliva production (antidepressants, diuretics, analgesics, antihistamines, anti-hyper/hypo-tensives, anti-anxiety, appetite suppressants).
  • Current or previous use of phosphodiesterase 5 (PDE5) inhibitors.
  • Participation in another clinical trial within past 4 weeks.
  • Participation in another PepsiCo study within the past 6 months.
  • Highly trained or elite endurance athlete as determined by current or recent (within 3 months) participation in an endurance sport at international or national level.

研究组 & 干预措施

Active Nitrate Bar

Experimental

include dietary nitrate; L-citrulline; epicatechin; vitamin C and glutathione

干预措施: Active Nitrate Bar (Other)

Placebo Bar

Placebo Comparator

Containing no active ingredients

干预措施: Placebo Bar (Other)

结局指标

主要结局

Mean power output during intermittent exercise test

时间窗: 5 days of intervention

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 (1)

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