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NCT05616585 · ClinicalTrials.gov registry record · NA
Dietary Biomarkers Intervention Core
A NA study of Diet, Healthy and Nutrition, Healthy, sponsored by Harvard School of Public Health (HSPH).
- Completed
- Registry status
- NA
- Development phase
- 115
- Enrollment target
- 1
- Study location
NCT05616585: Completed NA study of Diet, Healthy and Nutrition, Healthy, sponsored by Harvard School of Public Health (HSPH).
NCT05616585 is a NA study of Diet, Healthy and Nutrition, Healthy that has completed, run by Harvard School of Public Health (HSPH). The registered enrollment target is 115 participants, below the 505-participant average among 48 other Diet, Healthy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05616585, a NA study of Diet, Healthy and Nutrition, Healthy, has completed, sponsored by Harvard School of Public Health (HSPH).
- COMPLETED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies. This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial. * In the PK study, eight foods will be tested, each on a single day, and the design is crossover. * In the DR, the effects of 10 foods will be compared to each other in a randomized, parallel-group design, and the dose-effect of each of the 10 foods will be determined in a randomized, crossover design.
Primary Outcome
Urine samples are taken at baseline and postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomarker identification studies. A number of biomarkers will be identified for the test foods. These biomarkers will be measured using liquid chromatography-mass spectrometry (LC/MS) and nuclear magnetic resonance (NMR) spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which
Conditions Studied
Interventions
- OTHER Pharmacokinetic (PK)- Controlled Feeding Diet
- OTHER Dose Response (DR)- Controlled Feeding Diet
Study Locations (1)
Massachusetts
- Mass General Brigham Center for Clinical Investigation - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2025-10-01 |
| Phase | NA |
What the finished NCT05616585 record still lists
NCT05616585 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 505-participant average among 48 other Diet, Healthy trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Diet, Healthy appearing as the primary indexed condition, and to 2 interventions - of which Pharmacokinetic (PK)- Controlled Feeding Diet is the first listed.
NCT05616585 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05616585 about?
NCT05616585 is a clinical study titled "Dietary Biomarkers Intervention Core". The purpose of this controlled feeding trial is to establish an Intervention Core, equipped to perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies. This research is a two-component pharmacokinetic and pharmacodynamic cross-over dietary feeding trial. * In the PK ...
What is the current status of trial NCT05616585?
This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2023-02-01. Estimated completion is 2025-10-01.
What conditions does trial NCT05616585 study?
This clinical trial studies the following conditions: Diet, Healthy, Nutrition, Healthy, Metabolomics, Biological Markers.
What interventions are being tested in trial NCT05616585?
The interventions under investigation include: Pharmacokinetic (PK)- Controlled Feeding Diet (OTHER), Dose Response (DR)- Controlled Feeding Diet (OTHER).
Who is sponsoring clinical trial NCT05616585?
This trial is sponsored by Harvard School of Public Health (HSPH), which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05616585 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diet, Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05616585's enrollment target sits among peer trials
115 23rd of 48 higher than 26 of 48 other Diet, Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diet, Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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