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Dietary Biomarkers Intervention Core

NCT05616585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-10-07

No results posted yet for this 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.

Conditions

  • Biological Markers
  • Diet, Healthy
  • Metabolomics
  • Nutrition, Healthy

Interventions

OTHER

Pharmacokinetic (PK)- Controlled Feeding Diet

Pharmacokinetic- single-day isocaloric meals of beef, potatoes, chicken, whole wheat bread, corn, cheese, yogurt, and oats with blood and urine samples taken at Time Zero and every hour (blood) or two hours (urine) after eating, over 10 hours; and at 24 hr.

OTHER

Dose Response (DR)- Controlled Feeding Diet

Dose Response-3 level, six days controlled feeding study with assignment to either beef/whole wheat bread, chicken/potato, salmon/corn, cheese/soybeans, or yogurt/oats within a standard diet at zero, medium, and high doses for 6 days.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Frank M Sacks, MD · Harvard School of Public Health (HSPH)

  • Jonathan S Williams, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-08-31
Completion
2025-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05616585 on ClinicalTrials.gov