Daily Vinegar Ingestion and Metabolic Health

Sponsor

Arizona State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05698381

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammation Metabolic Syndrome Depression	Dietary Supplement: Liquid vinegar Dietary Supplement: Vinegar pill	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

Single (Participant)

Masking Description:

liquid vinegar (contains active dose of acetic acid) vinegar pill (contains only a trace of acetic acid)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

metabolic syndrome [change from baseline at week 4]
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)
Inflammation [change from baseline at week 4]
Blood C-reactive protein
LPS [change from baseline at week 4]
Blood Lipopolysaccharide binding protein

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.