NCT04706806

Brief Summary

The objective of this research is to record mood states and depression levels in healthy college students before and after 4 weeks of daily vinegar ingestion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 11, 2021

Last Update Submit

January 11, 2021

Conditions

MoodDepression

Keywords

acetic acid

Outcome Measures

Primary Outcomes (2)

  • mood state

    Profile of Mood States (POMS) questionnaire score

    change from baseline at day 28

  • depression

    Center for Epidemiologic Studies Depression Scale (CES-D)

    change from baseline at day 28

Study Arms (2)

liquid vinegar

EXPERIMENTAL

2 tablespoons (diluted in water) taken twice daily with meals

Dietary Supplement: apple cider vinegar

vinegar pill

PLACEBO COMPARATOR

1 vinegar pill taken daily

Dietary Supplement: vinegar pill

Interventions

apple cider vinegarDIETARY_SUPPLEMENT

2 tablespoons diluted in water taken twice daily with meals

Also known as: apple cider vinegar (Bragg Live Food Products, LLC)
liquid vinegar
vinegar pillDIETARY_SUPPLEMENT

one pill taken daily

Also known as: Nature's Bounty Apple Cider Vinegar pills
vinegar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • college student, non-athlete, no chronic health condition

You may not qualify if:

  • vegetarians or others adhering to special diet, body mass index \>30 kg/m2, pregnancy/lactation, unwilling to ingest vinegar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both groups received vinegar, either liquid form (active) or pill form (placebo)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

September 29, 2020

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)