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临床试验/NCT03577834
NCT03577834已完成不适用

The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration

Carol Johnston0 个研究点目标入组 102 人开始时间: 2017年1月5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
发起方
入组人数
102
主要终点
visceral adiposity

研究概览

简要总结

The purpose of this study is to test the potential ability of vinegar to significantly decrease visceral fat in healthy adults with "central obesity". During the 8-week trial, participants will either consume a low-dose vinegar pill (control treatment) or a vinegar drink twice per day.

Research Aim and Hypothesis H1 Daily vinegar consumption will be associated with loss in visceral fat (as measured by DXA) after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy adults with "central obesity".

H2 Daily vinegar consumption will be associated with a decrease in abdominal circumference after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy adults with "central obesity".

详细描述

This randomized, placebo-controlled experimental trial will last 8 weeks. At the initial visit (consenting visit lasting about 20 minutes) the participant will sign the consent and complete a short health questionnaire and a short questionnaire on tooth erosion. Body height and weight and waist circumference will also be measured. Qualifying participants will be stratified by gender, age, weight, and waist circumference, then randomized into two groups: the intervention group, vinegar drinks (VIN) or the control group, vinegar pills (CON). The participants will know which treatment they are given but they will not know which group (control vs. placebo) they are in. Those who receive the VIN will be instructed to drink 2 tablespoons of red wine vinegar (provided) mixed with water twice each day for weeks 1 to 8 of the trial. Those in the CON group will be instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial. Participants will be instructed to maintain their current diet and exercise habits during the study.

研究设计

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

盲法说明

All participants will receive 'vinegar' either in liquid form (active) or pill (not active as acetic acid concentration is below threshold of effect). Investigators measuring outcome variables (visceral fat, tooth enamel, and blood indices) are blinded to treatment assignment.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Nonsmoking
  • Not pregnant or lactating if female
  • No active disease state or medication use affecting blood glucose or cholesterol (additionally, individuals on digoxin or diuretics will be excluded but other medications in use >3 months will be allowed)
  • No food restrictions or special diet
  • BMI range: 22-35
  • Waist circumference >34 (women) and >39 (males)
  • Sedentary (exercising < 3 days/week)

排除标准

  • Unwilling to take a vinegar supplement daily for 8 week or follow other aspects of study protocol
  • Recent abdominal surgery or condition causing abdominal discomfort/distention (such as acid reflux, ascites, pancreatitis, diverticulitis/diverticulosis, Crohn's disease, and/or irritable bowel syndrome)

研究组 & 干预措施

Liquid vinegar

Experimental

Participants in this arm were instructed to drink 2 tablespoons of red wine vinegar (provided) mixed with water twice each day for weeks 1 to 8 of the trial.

干预措施: liquid vinegar (Dietary Supplement)

Vinegar pill

Placebo Comparator

Participants in the control group were instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial.

干预措施: vinegar pill (Dietary Supplement)

结局指标

主要结局

visceral adiposity

时间窗: change after 8 weeks of treatment

visceral fat as measured by DXA

次要结局

  • tooth erosion(change after 8 weeks of treatment)
  • insulin resistance(change after 8 weeks of treatment)

研究者

发起方
Carol Johnston
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carol Johnston

Professor and Associated Director

Arizona State University

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