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临床试验/NCT06319443
NCT06319443已完成不适用

Daily Vinegar Ingestion and 24-Hour Blood Glucose Control in Adults With Glucose Intolerance: A Randomized Crossover Trial

Arizona State University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年3月26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
10
试验地点
2
主要终点
Glucose: time in range

研究概览

简要总结

When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7.

Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant.

详细描述

Participants are randomly assigned to either Group A or Group B using the Microsoft Excel randomization function. Group A will be instructed to consume 4 tablespoons of red wine vinegar (2 tablespoons diluted in water at the start of the lunch and the dinner meals) for the first 4 days of the trial. Conversely, participants in Group B will ingest the placebo for the initial 4 days, ingesting one pill daily upon waking in the morning. On days 5-9, participants will switch to the opposite treatment. The red wine vinegar dosage (4 tablespoons containing 3.5 g acetic acid - this is the amount of acetic acid in a large 4-inch dill pickle), and the placebo vinegar pill dosage (one pill containing 0.022 g acetic acid) will be taken daily during the trial. On visit 1, anthropometric measurements, including height, weight, and body composition (lean fat mass and body fat mass), will be measured, and the continuous glucose monitor will be placed on the upper arm. The participants will be instructed to fast >8 hours (no food or beverages with the exception of water) ahead of visit 1. To ensure accurate use and data collection, researchers discussed the operation of CGM devices and that these waterproof devices are to be continuously worn during the entire 9-day trial and will be removed on day 9 (visit 2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Liquid and pill vinegar will be the treatments. The pill is the 'control' as the level of acetic acid is below the amount needed for an antiglycemic effect (a fact not realized by the participant).

入排标准

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

入选标准

  • glucose intolerance (defined as one of the following: fasting glucose >99 mg/dl; diagnosis of prediabetes or diabetes; history of gestational diabetes)
  • 18 years of age or older
  • sedentary or moderately active (defined as a score ≤ 24 on the Godin-Shepard Leisure Time Physical Activity Questionnaire)

排除标准

  • currently adhering to a non-typical diet that would impact carbohydrate intake (including weight loss diets)
  • medication/drug use that has not been consistent for the previous 3 months or will be discontinued during the trial
  • any acute illness
  • regular smokers, pregnant or lactating women, or individuals taking insulin
  • Unwilling to tolerate vinegar ingestion

结局指标

主要结局

Glucose: time in range

时间窗: Four days

The average time over 4 days that blood glucose falls in the reference range

Average glucose

时间窗: Four days

The average blood glucose concentration for each 4-day period

次要结局

未报告次要终点

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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