Depression Clinical Trial
Official title:
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State, Inflammatory State, and Risk for Metabolic Syndrome in Healthy Adults
Verified date | January 2024 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 15, 2023 |
Est. primary completion date | August 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | 850 PBC | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression score | Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe) | change from baseline at week 4 | |
Primary | 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 | |
Primary | gamma-aminobutyric acid (GABA) | Blood levels of the neurotransmitter GABA | change from baseline at week 4 | |
Secondary | 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 | |
Secondary | Inflammation | Blood C-reactive protein | change from baseline at week 4 | |
Secondary | LPS | Blood Lipopolysaccharide binding protein | change from baseline at week 4 |
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