Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female adults over the age of 18 years
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
L-Phenylalanine 500 mg Veg Capsule product
Drug500 mg Veg Capsule product
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: HealthyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, Week 2 (Day 14)2
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.
Time frame
Baseline, Week 2 (Day 14)3
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
Time frame
Baseline, Week 2 (Day 14)Secondary outcomes
1
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
Time frame
Baseline, Week 4 (Day 28)2
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.
Time frame
Baseline, Week 4 (Day 28)3
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
Time frame
Baseline, Week 4 (Day 28)Sponsors and contacts
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Source ClinicalTrials.gov