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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid vinegar | Experimental | 4 tablespoons BID per day (3000 mg acetic acid) |
|
| Vinegar pill | Placebo Comparator | 2 vinegar pills per day (30 mg acetic acid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid vinegar | Dietary Supplement | 2 tablespoons consumed twice daily with meals |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol S Johnston, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 850 PBC | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D024821 | Metabolic Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| ID | Term |
|---|---|
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized controlled trial
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liquid vinegar (contains active dose of acetic acid) vinegar pill (contains only a trace of acetic acid)
| Vinegar pill |
| Dietary Supplement |
2 pills consumed upon waking |
|
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |