LPSNCT06437405
Resistance Exercise Plus Vinegar Ingestion on Biomarkers in Healthy Adults
A study testing Vinegar liquid and vinegar pill in people with LPS and Mood Disorders, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- LPS, Mood Disorders, Cognitive Change
- What is being tested?
- Vinegar liquid and vinegar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- LPS, Mood Disorders, Cognitive Change
- Being tested
- Vinegar liquid, vinegar pill
- Keywords
- vinegar, resistance training, strength, depression
- Medical subject headings
- Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinegar liquidDietary supplement
Also called Vinegar pill
one pill daily
vinegar pillDietary supplement
One pill daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vinegar liquid |
| Vinegar pill | Placebo comparator | one apple cider vinegar tablet (0.022g acetic acid) daily. Receives: Dietary Supplement: vinegar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipopolysaccharide
measured indirectly via LPS binding protein
Measured: 12 weeks
Depression
measured via Profile of Mood States (POMS) questionnaire
Measured: 12 weeks
Cognitive change
measured using Trail Making Test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start22 May 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LPSStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-week randomized controlled trial preceded by a 3-week control period
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437405
- Sponsor's protocol ID
- STUDY00019774
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data beyond study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 12-Week Resistance Exercise Program Plus Vinegar Ingestion on Biomarkers of Intestinal Permeability, Cognition, and Mood State in Healthy Adults
- ClinicalTrials.gov ID
- NCT06437405
- Acronym / sponsor ID
- STUDY00019774
- Conditions
- LPS, Mood Disorders, Cognitive Change
- Keywords
- vinegar, resistance training, strength, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 12-week randomized controlled trial preceded by a 3-week control period
| Arm | Type | Receives |
|---|---|---|
| Liquid vinegar | Experimental | Dietary Supplement: Vinegar liquid2 tablespoons of liquid apple cider vinegar (5% acidity) diluted in one cup of water twice daily with meals providing 1.5g acetic acid. |
| Vinegar pill | Placebo comparator | Dietary Supplement: vinegar pillone apple cider vinegar tablet (0.022g acetic acid) daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinegar liquidAlso: Vinegar pillone pill daily | Dietary supplement | Liquid vinegar |
| vinegar pillOne pill daily | Dietary supplement | Vinegar pill |
Primary outcome
Lipopolysaccharide
Time frame: 12 weeks
measured indirectly via LPS binding protein
Depression
Time frame: 12 weeks
measured via Profile of Mood States (POMS) questionnaire
Cognitive change
Time frame: 12 weeks
measured using Trail Making Test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share data beyond study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vinegar liquid and vinegar pill in people with LPS and Mood Disorders, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipopolysaccharide (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.