search
Back to results

Daily Vinegar Ingestion and Metabolic Health

Primary Purpose

Inflammation, Metabolic Syndrome, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liquid vinegar
Vinegar pill
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammation focused on measuring vinegar, acetic acid, LPS

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 850 PBCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liquid vinegar

Vinegar pill

Arm Description

4 tablespoons BID per day (3000 mg acetic acid)

2 vinegar pills per day (30 mg acetic acid)

Outcomes

Primary Outcome Measures

Depression score
Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)
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).
gamma-aminobutyric acid (GABA)
Blood levels of the neurotransmitter GABA

Secondary Outcome Measures

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)
Inflammation
Blood C-reactive protein
LPS
Blood Lipopolysaccharide binding protein

Full Information

First Posted
January 16, 2023
Last Updated
April 23, 2023
Sponsor
Arizona State University
search

1. Study Identification

Unique Protocol Identification Number
NCT05698381
Brief Title
Daily Vinegar Ingestion and Metabolic Health
Official Title
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State, Inflammatory State, and Risk for Metabolic Syndrome in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Metabolic Syndrome, Depression
Keywords
vinegar, acetic acid, LPS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
liquid vinegar (contains active dose of acetic acid) vinegar pill (contains only a trace of acetic acid)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liquid vinegar
Arm Type
Experimental
Arm Description
4 tablespoons BID per day (3000 mg acetic acid)
Arm Title
Vinegar pill
Arm Type
Placebo Comparator
Arm Description
2 vinegar pills per day (30 mg acetic acid)
Intervention Type
Dietary Supplement
Intervention Name(s)
Liquid vinegar
Intervention Description
2 tablespoons consumed twice daily with meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Vinegar pill
Intervention Description
2 pills consumed upon waking
Primary Outcome Measure Information:
Title
Depression score
Description
Patient Health Questionnaire (PHQ-9); scores range from 0 (none-minimal) to 27 (severe)
Time Frame
change from baseline at week 4
Title
Depression score
Description
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).
Time Frame
change from baseline at week 4
Title
gamma-aminobutyric acid (GABA)
Description
Blood levels of the neurotransmitter GABA
Time Frame
change from baseline at week 4
Secondary Outcome Measure Information:
Title
metabolic syndrome
Description
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)
Time Frame
change from baseline at week 4
Title
Inflammation
Description
Blood C-reactive protein
Time Frame
change from baseline at week 4
Title
LPS
Description
Blood Lipopolysaccharide binding protein
Time Frame
change from baseline at week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol S Johnston, PhD
Phone
4808387127
Email
carol.johnston@asu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol S Johnston, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
850 PBC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol S Johnston, PhD
Phone
602-965-2539
Email
carol.johnston@asu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Daily Vinegar Ingestion and Metabolic Health

We'll reach out to this number within 24 hrs