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COMPLETED NA

Dietary Biomarkers Intervention Core

NCT05616585 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 115 participants
Start Date 2023-02-01
Est. Completion 2025-10-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05616585

The ClinicalTrials.gov registry entry for NCT05616585 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Harvard School of Public Health (HSPH), which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05616585 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05616585?

This trial is sponsored by Harvard School of Public Health (HSPH), which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial