Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06433310

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Belfer Research Building

New York, 10022, United States

Location status: Recruiting

Location contact

Emilia T Vignogna, BS

CONTACT

[email protected]

505-259-4995

Iliyan D Iliev, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Phenylalanine 500 mg Veg Capsule product

Drug

500 mg Veg Capsule product

Primary outcomes

  1. Changes in phenylpropionic acid levels from baseline in subject fecal material

    Time frame: Baseline, Week 2 (Day 14)

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

  2. Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material and swabs

    Time frame: Baseline, Week 2 (Day 14)

    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.

  3. 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)

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

Secondary outcomes

  1. Change in phenylpropionic acid levels from baseline in subject fecal material

    Time frame: Baseline, Week 4 (Day 28)

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

  2. Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material

    Time frame: Baseline, Week 4 (Day 28)

    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.

  3. 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)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emilia T Vignogna, BS

CONTACT

[email protected]

505-259-4995

Tsering D Sherpa-Ngima, BSc

CONTACT

[email protected]

929-328-9571

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 29, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.