## Protocol Section
### Identification Module
**NCT ID:** NCT06437405

**Brief Title:** Resistance Exercise Plus Vinegar Ingestion on Biomarkers in Healthy Adults

**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

#### Organization Study ID Info
**ID:** STUDY00019774
#### Organization
**Class:** OTHER
**Full Name:** Arizona State University
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Arizona State University

#### Responsible Party

**Investigator Affiliation:** Arizona State University

**Investigator Full Name:** Carol Johnston

**Investigator Title:** Professor and Associate Dean

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- LPS

- Mood Disorders

- Cognitive Change

**Keywords:**

- vinegar

- resistance training

- strength

- depression

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 12-week randomized controlled trial preceded by a 3-week control period

##### Masking Info

**Masking:** SINGLE

**Masking Description:** participants will be randomly assigned to the liquid vinegar group or the vinegar pill group (control)

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: Vinegar liquid

**Label:** Liquid vinegar

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: vinegar pill

**Label:** Vinegar pill

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Liquid vinegar

**Description:** one pill daily

**Name:** Vinegar liquid

**Other Names:**

- Vinegar pill

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Vinegar pill

**Description:** One pill daily

**Name:** vinegar pill

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** measured indirectly via LPS binding protein

**Measure:** Lipopolysaccharide

**Time Frame:** 12 weeks

**Description:** measured via Profile of Mood States (POMS) questionnaire

**Measure:** Depression

**Time Frame:** 12 weeks

**Description:** measured using Trail Making Test

**Measure:** Cognitive change

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** carol.johnston@asu.edu

**Name:** Carol Johnston, PhD

**Phone:** 6024962539

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Phoenix

**Contacts:**

***Contact 1:***

- **Email:** carol.johnston@asu.edu

- **Name:** Carol S Johnston, PhD

- **Phone:** 602-965-2539

- **Role:** CONTACT

**Country:** United States

**Facility:** 850 PBC

**State:** Arizona

**Status:** RECRUITING

**Zip:** 85004

### IPD Sharing Statement Module

**Description:** There is no plan to share data beyond study investigators.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: HIGH

- As Found: Mood Disorders

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019964

- Term: Mood Disorders

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M21319

- Name: Acetic Acid

- Relevance: HIGH

- As Found: Anorectal

- ID: M303111

- Name: Retinol acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T436

- Name: Acetic Acid

- Relevance: HIGH

- As Found: Anorectal

### Intervention Browse Module - Meshes

- ID: D000019342

- Term: Acetic Acid

### Misc Info Module

- Version Holder: 2024-05-31
