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临床试验/NCT01884727
NCT01884727已完成不适用

A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of ASEA on Energy Expenditure and Fat Oxidation in Humans

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Resting Energy Expenditure

研究概览

简要总结

To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis: consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo control (salt water, same dietary intake).

详细描述

The ASEA beverage is a special oral formulation produced from a pure saline solution containing 123 mg sodium and 129 mg chloride per 4 oz. serving. A proprietary electrolytic and catalytic process rearranges the salt water solution to mimic the redox signaling molecular composition of the native salt-water compounds found in and around human cells. Data obtained thus far, suggests the possibility that consumption of the ASEA beverage may increase energy expenditure and thus be beneficial for the treatment of obesity, however, this has not been assessed in human clinical studies. To this end, we will measure the effects of ASEA consumption on energy expenditure by indirect calorimetry using the indirect room calorimeter at the University of North Carolina (UNC) Nutrition Research Institute.

The primary outcome measures will be the change in 24-h energy expenditure and respiratory quotient in response to ASEA consumption. The secondary outcome variables will include changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship to changes in energy expenditure in response to consumption of ASEA.

研究设计

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

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • postmenopausal
  • age 50-65
  • BMI 25-35 kg/m²
  • exercise less than 150 minutes per week
  • weight neutral for past 6 months

排除标准

  • exercises more than 150 minutes per week
  • abuses drugs or alcohol
  • vegetarian
  • taking herbal supplements, attention deficit hyperactivity disorder (ADHD) medication or thyroid medication
  • taking beta-blockers, steroidal anti-inflammatory medication
  • taking pseudoephedrine

结局指标

主要结局

Resting Energy Expenditure

时间窗: 24-hours

Changes in 24-h resting energy expenditure and respiratory quotient (RQ) in response to ASEA or control salt water to be measured by indirect calorimetry in the room indirect calorimeter at the UNC Nutrition Research Institute.

次要结局

  • Plasma Hormones(0900 and 1100 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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