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临床试验/NCT05698381
NCT05698381已完成不适用

Effect of Daily Vinegar Ingestion for Four Weeks on Mood State, Inflammatory State, and Risk for Metabolic Syndrome in Healthy Adults

Arizona State University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
gamma-aminobutyric acid (GABA)

研究概览

简要总结

The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.

详细描述

Recent research, in animal and human subjects, suggests that vinegar intake is inversely associated with insulin resistance, mood states and depression, inflammation, and other disease parameters. The study will be conducted as a randomized controlled trial in overweight adults to further examine these relationships and possible mechanisms. Although the mechanisms are not known, research suggests that changes in the gut microbiome, a response to the ingestion of the postbiotic acetic acid, may factor into the beneficial effects of vinegar ingestion. Through analyses of blood, changes in key blood metabolites associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health (e.g., LPS binding protein) and inflammation (e.g., CRP) will be assessed. Additionally mood state will be assessed using validated measures and determine risk for metabolic syndrome, a cluster of risk factors associated with many chronic conditions. It is hypothesized that vinegar ingestion will promote beneficial changes to these health parameters.

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
Single (Participant)

盲法说明

liquid vinegar (contains active dose of acetic acid) vinegar pill (contains only a trace of acetic acid)

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

  • non-smoker
  • free of chronic disease by self-report
  • able to speak, read, and understand English
  • able to consent.
  • BMI ≥ 25 and ≤ 35

排除标准

  • adherence to specific diets for weight loss
  • vegetarian
  • report GERD or regular heartburn
  • unwilling to consume vinegar daily for 4 weeks
  • pregnant or lactating women
  • recreational drug use, alcohol intake above recommendations (1 drink/day for women, 2 drinks/day for men - or none)
  • competitive level physical training (e.g., physical activity above recommendations as set by the Physical Activity Guidelines for Americans)
  • scoring 1 or higher on question 9 of the PHQ-9 questionnaire.

结局指标

主要结局

gamma-aminobutyric acid (GABA)

时间窗: change from baseline at week 4

Blood levels of the neurotransmitter GABA

Depression score

时间窗: change from baseline at week 4

Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)

次要结局

  • Inflammation(change from baseline at week 4)
  • metabolic syndrome(change from baseline at week 4)
  • LPS(change from baseline at week 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carol Johnston

Professor and Associate Dean

Arizona State University

研究点 (2)

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