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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06433310
Phase
PHASE4
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • L-Phenylalanine 500 mg Veg Capsule product — DRUG
    500 mg Veg Capsule product

Study Details

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.

Key Dates

Start date
Oct 17, 2024
Status verified
Apr 2026
Primary completion
Dec 17, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.

Primary Outcome Measure

Changes in phenylpropionic acid levels from baseline in subject fecal material [ Time Frame: Baseline, Week 2 (Day 14) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Belfer Research BuildingNew YorkNew York10022
Aurelia Li, MS
732-822-6836
Iliyan D Iliev, PhD (PRINCIPAL_INVESTIGATOR)

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