Dietary Biomarkers Intervention Core

Description

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

Study Overview

Study Details

Study overview

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.

Dietary Biomarkers Development Center at Harvard University: Intervention Core

Dietary Biomarkers Intervention Core

Condition
Biological Markers
Intervention / Treatment

-

Contacts and Locations

Boston

Mass General Brigham Center for Clinical Investigation, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy adults Men and women, 18+
  • * Body Mass Index (BMI) 18.5-39.9 kg/m2
  • * Willingness to participate in all study visits
  • * 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
  • * Diuretics
  • * Steroids (oral): daily oral any dose within 1 month of study, except as noted below
  • * Nonsteroidal anti-inflammatory drugs (NSAIDS): when prescribed for treatment or is regularly consumed (i.e.. Daily), or can't be stopped for 2 days without pain, except 81 mg Aspirin
  • * Opiates: any use within 1 month of study
  • * Antilipemic Agents that affect GI or renal function (i.e.. Fibrates)
  • * Antidiabetics and Hypoglycemic medications other than metformin (i.e.. insulin, SGLT2 inhibitor, α-glucosidase inhibitor)
  • * Psychiatric that affect metabolism/renal function (anti-psychotics, lithium)
  • * Biologics/immune modulators (i.e.. rheumatoid arthritis (RA), psoriasis, other rheumatologic/hematologic active disease)
  • * Anti-coagulants (coumadin, heparin, Eliquis, etc.)
  • * Human immunodeficiency virus (HIV) or highly active antiretroviral therapy (HAART) , etc.
  • * Medications that are approved: Steroids (nasal or topical), Aspirin, NSAIDS and Tylenol (avoid day before and day of study visit, Statins, Metformin, Psychiatric drugs other than anti-psychotics (SSRI, tricyclics, benzo), oral contraception pill (OCP)/Hormonal Replacement Therapy (HRT), Tobacco cessation products (patches/lozenge), Oral contraceptives, Gender- affirming HRT, Testosterone for hypogonadal males.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Harvard School of Public Health (HSPH),

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

Jonathan S Williams, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2025-06