Daily Vinegar Ingestion and Metabolic Health

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

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

Study Overview

• Status: Completed
• Conditions: Depression; Inflammation; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Liquid vinegar; Dietary supplement: Vinegar pill

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • 850 PBC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid vinegar; 4 tablespoons BID per day (3000 mg acetic acid)	Dietary supplement: Liquid vinegar; 2 tablespoons consumed twice daily with meals
Placebo Comparator: Vinegar pill; 2 vinegar pills per day (30 mg acetic acid)	Dietary supplement: Vinegar pill; 2 pills consumed upon waking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gamma-aminobutyric acid (GABA)	Blood levels of the neurotransmitter GABA	change from baseline at week 4
Depression score	Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)	change from baseline at week 4
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	Blood C-reactive protein	change from baseline at week 4
LPS	Blood Lipopolysaccharide binding protein	change from baseline at week 4
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

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: Carol S Johnston, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: LPS; acetic acid; vinegar
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Inflammation; Metabolic Syndrome; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: STUDY00017204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No