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Completed

NCT Number: NCT05698381

Daily Vinegar Ingestion and Metabolic Health

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

850 PBC

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liquid vinegar

Dietary Supplement

2 tablespoons consumed twice daily with meals

Vinegar pill

Dietary Supplement

2 pills consumed upon waking

Primary outcomes

  1. Depression score

    Time frame: change from baseline at week 4

    Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)

  2. Depression score

    Time frame: 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).

  3. gamma-aminobutyric acid (GABA)

    Time frame: change from baseline at week 4

    Blood levels of the neurotransmitter GABA

Secondary outcomes

  1. metabolic syndrome

    Time frame: 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)

  2. Inflammation

    Time frame: change from baseline at week 4

    Blood C-reactive protein

  3. LPS

    Time frame: change from baseline at week 4

    Blood Lipopolysaccharide binding protein

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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