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

NCT06433310 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-09026469
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 fungal populations of the gut microbiome.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Changes in phenylpropionic acid levels from baseline in subject fecal material

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

  Baseline, Week 2 (Day 14)

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

  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.

  Baseline, Week 2 (Day 14)

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

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

  Baseline, Week 2 (Day 14)

Secondary Outcomes (3)

• Change in phenylpropionic acid levels from baseline in subject fecal material

  Baseline, Week 4 (Day 28)

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

  Baseline, Week 4 (Day 28)

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

  Baseline, Week 4 (Day 28)

Study Arms (1)

Healthy

EXPERIMENTAL

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.

Drug: L-Phenylalanine 500 mg Veg Capsule product

Interventions

L-Phenylalanine 500 mg Veg Capsule product DRUG

500 mg Veg Capsule product

Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults over the age of 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Belfer Research Building

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Interventions

Phenylalanine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Iliyan D Iliev, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelia Li, MS

CONTACT

732-822-6836; aul4004@med.cornell.edu

Tsering D Sherpa-Ngima, BSc

CONTACT

929-328-9571; tss4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)