Daily Vinegar Ingestion and Metabolic Health

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

Detailed Description
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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.

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

Conditions
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Inflammation, Metabolic Syndrome, Depression

Intervention / Treatment
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* Dietary Supplement: Liquid vinegar
* Dietary Supplement: Vinegar pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vinegar, acetic acid, LPS