## Protocol Section
### Identification Module
**NCT ID:** NCT06433310

**Brief Title:** Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study

**Official Title:** Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study

#### Organization Study ID Info
**ID:** 23-09026469
#### Organization
**Class:** OTHER
**Full Name:** Weill Medical College of Cornell University
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Weill Medical College of Cornell University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes in fungal populations in the gut microbiome.

**Detailed Description:** The human gastrointestinal tract hosts a diverse microbial community that has a role in influencing the host's pathophysiological responses. Although there is an abundance of metagenomic data available, the functional dynamics of the gut microbiota still need exploration in different conditions. The microbiota produces various metabolites from dietary products, impacting both host health and pathophysiological functions. The metabolites produced by different microbiota may selectively suppress or stimulate the growth of some components of the gut microbiome, ultimately influencing the dynamic of gut bacterial and fungal populations. Our lab is specifically interested in a metabolite, known as phenylpropionic acid (PPA) produced by a human gut resident bacteria known as Clostridium sporogenes. C.sporogenes produces PPA by metabolizing the amino acid, L-phenylalanine, which is sourced from human diet. Many studies have observed the antimicrobial and antifungal effects of PPA. Our lab determined the antifungal activity of PPA through decreased levels of Candida albicans in the mouse gut. We are interested in investigating how diversity in mycobiota populations, which focuses on the fungi species in the human gut, are related to changes in PPA levels.

Therefore, this study will assess whether additional oral supplementation of L-Phenylalanine has any effect on the way C. sporogenes metabolizes phenylalanine. Healthy subjects will receive a 14-day supply of L-phenylalanine supplements and will provide stool and blood samples to the study team.

### Conditions Module

**Conditions:**

- Gut Microbiome

- Gut Health

- Dietary Supplement

- L-Phenylalanine

- Phenylpropionic Acid

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive one bottle of L-Phenylalanine 500 mg Veg Capsule product on Day 0. All subjects will be asked to start taking the supplement on Day 1 continuing until Day 14. They will be asked to take 2x 500 mg capsules in the morning and 1x 500 mg capsule in the evening daily for 14 days.

**Intervention Names:**

- Dietary Supplement: L-Phenylalanine 500 mg Veg Capsule product

**Label:** Healthy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy

**Description:** 500 mg Veg Capsule product

**Name:** L-Phenylalanine 500 mg Veg Capsule product

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention

**Measure:** Change in phenylpropionic acid levels from baseline in subject fecal material

**Time Frame:** Baseline, Week 2 (Day 14)

**Description:** Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis.

**Measure:** Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material

**Time Frame:** Baseline, Week 2 (Day 14)

**Description:** Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens

**Measure:** Change in the number of T cells that react to fungal antigens from baseline in subject blood samples

**Time Frame:** Baseline, Week 2 (Day 14)

#### Secondary Outcomes

**Description:** Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention

**Measure:** Change in phenylpropionic acid levels from baseline in subject fecal material

**Time Frame:** Baseline, Week 4 (Day 28)

**Description:** Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis.

**Measure:** Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material

**Time Frame:** Baseline, Week 4 (Day 28)

**Description:** Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens

**Measure:** Change in the number of T cells that react to fungal antigens from baseline in subject blood samples

**Time Frame:** Baseline, Week 4 (Day 28)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female adults over the age of 18 years

Exclusion Criteria:

* History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease
* Antibiotic usage within the past two weeks
* Antifungal usage within the past month
* Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU)
* Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening)
* Pregnant or nursing women

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tss4002@med.cornell.edu

**Name:** Tsering D Sherpa-Ngima, BSc

**Phone:** 929-328-9571

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** tss4002@med.cornell.edu

- **Name:** Tsering D Sherpa-Ngima, BSc

- **Phone:** 929-328-9571

- **Role:** CONTACT

***Contact 2:***

- **Name:** Iliyan D Iliev, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Belfer Research Building

**State:** New York

**Zip:** 10022

#### Overall Officials

**Official 1:**

**Affiliation:** Weill Medical College of Cornell University

**Name:** Iliyan D Iliev, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: AA

- Name: Amino Acids

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T14

- Name: Phenylalanine

- Relevance: HIGH

- As Found: Glass

### Misc Info Module

- Version Holder: 2024-05-31
