Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID06433310

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

Led by Weill Medical College of Cornell University · Updated on 2026-05-04

20

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the dietary supplement L-Phenylalanine affects the production of phenylpropionic acid (PPA) and changes in fungal populations in the gut microbiome of healthy adults. The study focuses on the role of gut bacteria, specifically Clostridium sporogenes, which produces PPA by metabolizing L-Phenylalanine from the diet. This metabolite has been shown to have antifungal effects in animal studies, and the research aims to understand its impact on human gut fungi, especially Candida species. Participants will receive a 14-day supply of L-Phenylalanine capsules, taking two 500 mg capsules in the morning and one 500 mg capsule in the evening each day. The study includes a single group of healthy volunteers who will take the supplement and provide stool and blood samples before starting and after the 14-day supplementation period. This intervention will allow researchers to assess how L-Phenylalanine intake influences gut fungal populations and PPA levels. Throughout the study, participants will provide stool and blood samples at baseline and on Day 14 to measure changes in phenylpropionic acid levels, fungal populations including gut Candida levels, and the number of T cells reacting to fungal antigens. Additional follow-up samples at Day 28 will also assess these changes. The study involves monitoring immune responses and gut microbiome shifts to understand the supplement's effects. Participation lasts for at least 28 days including follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female adults over the age of 18 years
Not Eligible

You will not qualify if you...

  • 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
  • Pregnant or nursing women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 days

Participants take L-Phenylalanine supplements daily for 14 days and provide stool and blood samples to assess changes in fungal mycobiota and phenylpropionic acid levels.

1 baseline visit and 1 follow-up visit on Day 14

Follow-up

Duration - 14 days

Participants provide stool and blood samples to assess longer-term changes in fungal mycobiota and phenylpropionic acid levels after supplementation ends.

1 follow-up visit on Day 28

Trial Site Locations

Total: 1 location

1

Belfer Research Building

New York, New York, United States, 10022

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Research Team

A

Aurelia Li, MS

T

Tsering D Sherpa-Ngima, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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