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

Weill Cornell Medicine (WCM)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Gut Microbiome; Phenylpropionic Acid; L-Phenylalanine; Gut Health; Dietary Supplement

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06433310

23-09026469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Healthy

Experimental group

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.

Treatment:

Dietary Supplement: L-Phenylalanine 500 mg Veg Capsule product