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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2026-12-31

Brief Summary

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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 fungal populations of the gut microbiome.

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Detailed Description

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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 PPA holds antifungal activity of PPA in the gut of mice colonized with Candida albicans. We are interested in investigating how diversity in the mycobiota populations, which focuses on the fungi species in the human gut, are related to changes in PPA levels.

Therefore, this study will asses whether additional oral supplementation of L-phenylalanine has an effect on the way gut mycobiota responds to this amino acid. Healthy subjects received a 14-day supply of L-phenylalanine supplements and provided stool and blood samples to the study team.

Conditions

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Gut Microbiome Gut Health Dietary Supplement L-Phenylalanine Phenylpropionic Acid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy

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.

Group Type EXPERIMENTAL

L-Phenylalanine 500 mg Veg Capsule product

Intervention Type DRUG

500 mg Veg Capsule product

Interventions

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L-Phenylalanine 500 mg Veg Capsule product

500 mg Veg Capsule product

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes