Daily Vinegar Ingestion and Metabolic Health

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698381
• Other study ID #: STUDY00017204
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Inflammation
• Metabolic Syndrome
• Syndrome

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