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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05698381
Other study ID # STUDY00017204
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date August 15, 2023

Study information

Verified date January 2024
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - healthy - non-smoker - free of chronic disease by self-report - able to speak, read, and understand English - able to consent. - BMI = 25 and = 35 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Liquid vinegar
2 tablespoons consumed twice daily with meals
Vinegar pill
2 pills consumed upon waking

Locations

Country Name City State
United States 850 PBC Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression score Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe) change from baseline at week 4
Primary Depression score Center for Epidemiologic Studies Depression Scale (CES-D); scores range from 0 to 60 (higher scores suggest a greater presence of depressive symptoms. A score of 15 or higher is interpreted to indicate a risk for depression). change from baseline at week 4
Primary gamma-aminobutyric acid (GABA) Blood levels of the neurotransmitter GABA change from baseline at week 4
Secondary metabolic syndrome A cluster of conditions that increase risk of heart disease, stroke and type 2 diabetes: increased blood pressure, high blood sugar, waist circumference, and abnormal cholesterol or triglyceride levels. siMS score = 2*Waist/Height + Gly/5.6 + Tg/1.7 + TAsystolic/130-HDL/1.02 or 1.28 (for male or female subjects, respectively) (adapted from Soldatovic et al. (2016) siMS Score: Simple Method for Quantifying Metabolic Syndrome. PLoS ONE 11(1): e014614) change from baseline at week 4
Secondary Inflammation Blood C-reactive protein change from baseline at week 4
Secondary LPS Blood Lipopolysaccharide binding protein change from baseline at week 4
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