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

Gut Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433310
• Other study ID #: 23-09026469
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Tsering D Sherpa-Ngima, BSc
• Phone: 929-328-9571
• Email: tss4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 in fungal populations in the gut microbiome.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Supplement
• Gut Health
• Gut Microbiome

Intervention

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

Locations

Country	Name	City	State
United States	Belfer Research Building	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change 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)
Primary	Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material	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)
Primary	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	Change 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 4 (Day 28)
Secondary	Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material	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 4 (Day 28)
Secondary	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 4 (Day 28)