NCT06437405

Brief Summary

Given its capacity to stimulate exercise-induced neuroplasticity at lower doses compared to aerobic exercise, resistance exercise has become the top-recommended rehabilitation approach for individuals with neurocognitive impairments. Despite a large body of evidence supporting its application in the context of cognition, little work has been done to investigate the role of resistance exercise in modifying the structure and function of the microbiota-gut-brain axis. Likewise, despite a general understanding of the benefits of short chain fatty acids such as acetate for the gut-brain axis, the impact of exogenous acetic acid has not been sufficiently examined in the context of the intestinal barrier. While self-reported mood disturbance responds favorably to vinegar ingestion, it is currently unknown if these effects are also associated with changes in intestinal permeability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

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

May 22, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

April 9, 2025

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 26, 2024

Last Update Submit

April 6, 2025

Conditions

Keywords

vinegarresistance trainingstrengthdepression

Outcome Measures

Primary Outcomes (3)

  • Lipopolysaccharide

    measured indirectly via LPS binding protein

    12 weeks

  • Depression

    measured via Profile of Mood States (POMS) questionnaire

    12 weeks

  • Cognitive change

    measured using Trail Making Test

    12 weeks

Study Arms (2)

Liquid vinegar

EXPERIMENTAL

2 tablespoons of liquid apple cider vinegar (5% acidity) diluted in one cup of water twice daily with meals providing 1.5g acetic acid.

Dietary Supplement: Vinegar liquid

Vinegar pill

PLACEBO COMPARATOR

one apple cider vinegar tablet (0.022g acetic acid) daily.

Dietary Supplement: vinegar pill

Interventions

Vinegar liquidDIETARY_SUPPLEMENT

one pill daily

Also known as: Vinegar pill
Liquid vinegar
vinegar pillDIETARY_SUPPLEMENT

One pill daily

Vinegar pill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • premenopausal (for those assigned female at birth)
  • willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
  • sedentary (defined as a score \<14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ))
  • equipped with access to a complete gym
  • available for all lab visits (at weeks 0, 3, 9, and 15)

You may not qualify if:

  • antibiotic use within the past three months
  • prebiotic, probiotic, or high-dose antioxidant supplementation within the past month
  • regular engagement in moderate to vigorous exercise
  • following a vegetarian diet
  • presence of any medical/psychiatric disease
  • presence of any gastrointestinal disorder such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, diverticulitis/diverticulosis, etc.
  • actively pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

850 PBC

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Mood DisordersDepression

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral 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
participants will be randomly assigned to the liquid vinegar group or the vinegar pill group (control)
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 12-week randomized controlled trial preceded by a 3-week control period
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean

Study Record Dates

First Submitted

May 26, 2024

First Posted

May 31, 2024

Study Start

May 22, 2024

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

April 9, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share data beyond study investigators.

Locations