Resistance Exercise Plus Vinegar Ingestion on Biomarkers in Healthy Adults

Cognitive Change Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06437405
• Other study ID #: STUDY00019774
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Arizona State University
• Contact: Carol Johnston, PhD
• Phone: 6024962539
• Email: carol.johnston[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. premenopausal (for those assigned female at birth)

2. willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire

3. sedentary (defined as a score <14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ))

4. equipped with access to a complete gym

5. available for all lab visits (at weeks 0, 3, 9, and 15)

Exclusion Criteria:

1. antibiotic use within the past three months

2. prebiotic, probiotic, or high-dose antioxidant supplementation within the past month

3. regular engagement in moderate to vigorous exercise

4. following a vegetarian diet

5. presence of any medical/psychiatric disease

6. presence of any gastrointestinal disorder such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, diverticulitis/diverticulosis, etc.

7. actively pregnant or breastfeeding

Related Conditions & MeSH terms

• Cognitive Change
• LPS
• Mood Disorders

Intervention

Dietary Supplement:
• Vinegar liquid
one pill daily
• vinegar pill
One pill daily

Locations

Country	Name	City	State
United States	850 PBC	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipopolysaccharide	measured indirectly via LPS binding protein	12 weeks
Primary	Depression	measured via Profile of Mood States (POMS) questionnaire	12 weeks
Primary	Cognitive change	measured using Trail Making Test	12 weeks