- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437405
Resistance Exercise Plus Vinegar Ingestion on Biomarkers in Healthy Adults
April 6, 2025 updated by: Carol Johnston, Arizona State University
The Effects of a 12-Week Resistance Exercise Program Plus Vinegar Ingestion on Biomarkers of Intestinal Permeability, Cognition, and Mood State in Healthy Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Existing resistance exercise interventions have produced promising outcomes indicating favorable shifts in microbial composition, intestinal barrier integrity, and serum biomarkers of inflammation.
These changes appear to be particularly pronounced in individuals experiencing greater enhancements in lean mass, implying a crucial role for the hypertrophic effects of the exercise protocol.
Given the current knowledge surrounding age-related cognitive decline and the pathophysiology of neurological and psychiatric disorders, it seems that many of the mechanisms significantly influenced by resistance exercise could contribute to reducing the risk or, at the very least, delaying the onset of these conditions.
Considering the observed neuroplastic and neuroprotective effects of resistance exercise on the brain, it is plausible to hypothesize that the mitigation of excessive intestinal permeability and subsequent neuroinflammation may further support overall brain function.
Given the potential for vinegar to enhance these outcomes, investigating the combined effects of exercise and vinegar ingestion may provide valuable insights into how lifestyle interventions can effectively promote cognitive and mental health.
Therefore, the purpose of this work is to assess whether the combination of resistance exercise and vinegar ingestion elicits more favorable shifts in gut barrier function, cognition, and mental health compared to resistance exercise alone.
This investigation aims to demonstrate the potential efficacy of this integrated approach in fostering long-team health outcomes.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- 850 PBC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Liquid vinegar
2 tablespoons of liquid apple cider vinegar (5% acidity) diluted in one cup of water twice daily with meals providing 1.5g acetic acid.
|
one pill daily
Other Names:
|
|
Placebo Comparator: Vinegar pill
one apple cider vinegar tablet (0.022g acetic acid) daily.
|
One pill daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipopolysaccharide
Time Frame: 12 weeks
|
measured indirectly via LPS binding protein
|
12 weeks
|
|
Depression
Time Frame: 12 weeks
|
measured via Profile of Mood States (POMS) questionnaire
|
12 weeks
|
|
Cognitive change
Time Frame: 12 weeks
|
measured using Trail Making Test
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2024
Primary Completion (Actual)
February 15, 2025
Study Completion (Actual)
February 15, 2025
Study Registration Dates
First Submitted
May 26, 2024
First Submitted That Met QC Criteria
May 26, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00019774
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share data beyond study investigators.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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