Daily Vinegar Ingestion and Metabolic Health

NCT05698381 | Completed

• 1 other identifier: STUDY00017204
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammation; Metabolic Syndrome; Depression

Keywords

vinegar; acetic acid; LPS

Outcome Measures

Primary Outcomes (3)

• 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

• gamma-aminobutyric acid (GABA)

  Blood levels of the neurotransmitter GABA

  change from baseline at week 4

Secondary Outcomes (3)

• metabolic syndrome

  change from baseline at week 4

• Inflammation

  change from baseline at week 4

• LPS

  change from baseline at week 4

Study Arms (2)

Liquid vinegar

EXPERIMENTAL

4 tablespoons BID per day (3000 mg acetic acid)

Dietary Supplement: Liquid vinegar

Vinegar pill

PLACEBO COMPARATOR

2 vinegar pills per day (30 mg acetic acid)

Dietary Supplement: Vinegar pill

Interventions

Liquid vinegar DIETARY_SUPPLEMENT

2 tablespoons consumed twice daily with meals

Liquid vinegar

Vinegar pill DIETARY_SUPPLEMENT

2 pills consumed upon waking

Vinegar pill

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

850 PBC

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Inflammation; Metabolic Syndrome; Depression

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Carol S Johnston, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: liquid vinegar (contains active dose of acetic acid) vinegar pill (contains only a trace of acetic acid)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)