Inflammation, Metabolic Syndrome, Depression
Conditions
Keywords
vinegar, acetic acid, LPS
Brief summary
The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.
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.
Interventions
DIETARY_SUPPLEMENTLiquid vinegar
2 tablespoons consumed twice daily with meals
DIETARY_SUPPLEMENTVinegar pill
2 pills consumed upon waking
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
liquid vinegar (contains active dose of acetic acid) vinegar pill (contains only a trace of acetic acid)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression score | change from baseline at week 4 | Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe) |
| gamma-aminobutyric acid (GABA) | change from baseline at week 4 | Blood levels of the neurotransmitter GABA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed