Dietary Biomarkers Intervention Core

NCT05616585 | Completed DMC

• 2 other identifiers: IRB21-10671U2CDK129670-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.

  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 hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids, and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.

  Pharmacokinetic Phase1: [Time Frame: 0, 2, 4, 6, 8, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days controlled feeding of paired test foods.

• Serum/plasma biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.

  Blood 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 LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.

  Pharmacokinetic Phase 1 [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 24 hours post consumption of the test food.] Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days-controlled feeding of paired test foods.

• Stool biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.

  . Stool 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 LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.

  Dose Response Phase 2: [Time Frame: Day 0 and Day 7 post consumption of 6 days-controlled feeding of paired test foods.

Study Arms (2)

Pharmacokinetic

EXPERIMENTAL

Single Day Intervention of 10 test foods

Other: Pharmacokinetic (PK)- Controlled Feeding Diet

Dose Response

EXPERIMENTAL

Six day, 3 level (zero, medium, high dose) controlled feeding study

Other: Dose Response (DR)- Controlled Feeding Diet

Interventions

Pharmacokinetic (PK)- Controlled Feeding Diet OTHER

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.

Pharmacokinetic

Dose Response (DR)- Controlled Feeding Diet OTHER

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.

Dose Response

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mass General Brigham Center for Clinical Investigation

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Chakraborty H, Sun Q, Bhupathiraju SN, Schenk JM, Mishchuk DO, Bain JR, He X, Sun J, Harnly J, Simmons W, Raftery D, Liang L, Newman JW, Fiehn O, Clish CB, Lampe JW, Bennett BJ, Navarro SL, Wang Y, Zheng C, Mossavar-Rahmani Y, McCullough ML, Huang Y, Shojaie A, Zhu W, Djukovic D, Sacks F, Williams J, Steinberg FM, Adams SH, Hu FB, Neuhouser ML, Slupsky CM, Maruvada P. The Dietary Biomarkers Development Consortium: An Initiative for Discovery and Validation of Dietary Biomarkers for Precision Nutrition. Curr Dev Nutr. 2025 Apr 5;9(5):107435. doi: 10.1016/j.cdnut.2025.107435. eCollection 2025 May.

  PMID: 40641655 DERIVED

Related Links

• Harvard Dietary Biomarkers Website
• Biomarkers Consortium Website

Study Officials

• Frank M Sacks, MD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Jonathan S Williams, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 15, 2022
• Study Start: February 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: October 1, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (1)