Dietary Biomarkers Intervention Core

Completed · Not applicable

Conditions studied: Biological Markers, Diet, Healthy, Metabolomics, Nutrition, Healthy

In brief

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.

Key facts

Study ID: NCT05616585
Run by: Harvard School of Public Health (HSPH)
People needed: 115
Starts: 2023-02-01
Expected to finish: 2025-10-01
Last updated by the study team: 2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy adults Men and women, 18+
Body Mass Index (BMI) 18.5-39.9 kg/m2
Willingness to participate in all study visits

You may not qualify if…

History of gastrointestinal conditions (e.g., ulcerative colitis, Crohn disease, celiac sprue, Hereditary Non-polyposis Colorectal Cancer, familial adenomatous polyposis, pancreatic disease, liver disease)
Bleeding disorders that preclude blood draws
Anemia- as self-reported in the Screening Questionnaire
Previous gastrointestinal resection or gastric bypass surgery
Recent hospital admissions (in past 6 months) for heart disease (myocardial infarction, cerebrovascular accident, or congestive heart failure) or other cerebrovascular/ coronary artery disease condition under physician guided therapy that is not medically stable.
Cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment. Except for non-melanoma skin cancer.
Women who are pregnant or lactating
Weight change (±5% in3 months)
Regular alcohol intake of >2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits) and unwilling to abstain during feeding periods
Use of tobacco, marijuana, hookahs, vape, or e-cigarettes and not willing to abstain during feeding periods.
Use of illicit drugs and not willing abstain during feeding periods.
Body mass index >40 kg/m2
Hypertension- seated blood pressure >140 mmHg or diastolic >90 mmHg
Food allergies/intolerances or major dislikes to foods used in the study menus; unwilling to consume study foods.
Regular (daily to weekly) use of over-the-counter weight-loss aids, anti-inflammatories, and unwilling to stop taking these during feeding periods
Unwilling to stop taking over the counter dietary supplements that interfere with the test foods being studied, including pills, chewable, liquids or powders for the following: protein supplements, soy, fiber, flaxseed, fish oil (incl. cod liver oil), probiotics, carotenoids, selenium, other antioxidants, other phytochemicals, glucosamine, and chondroitin. If vitamin supplement is MD prescribed, the participant may be enrolled subject to the investigator's judgment. Staff will review supplement to determine eligibility.
Oral or IV antibiotic use in the past 3 months (could defer participation until 3 months post completion of course of antibiotics)
Inability to freely give informed consent
Clinical lab tests outside acceptable value as ascertained at a screening blood draw and current use of specific prescription medications per self-report
Description [Acceptable Values]
Glucose-Fasting: Serum Glucose [54-125 mg/dl]
Blood Urea Nitrogen [6-50mg/dl]
Serum Creatinine [0.4-1.3 mg/dl]
Estimated glomerular filtration rate (eGFR) [>60ml/min]
Serum Sodium [133-146 mmol/L]

Where it is running

Mass General Brigham Center for Clinical Investigation — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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