Dietary Biomarkers Intervention Core

Diet, Healthy Clinical Trial

Official title: Dietary Biomarkers Development Center at Harvard University: Intervention Core

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Diet is one of the most important determinants of human health and an essential component of population-wide primary prevention strategies. However, there is controversy about the quality and reliability of population- based nutrition research. The vast majority of evidence for healthy eating is informed by large studies with dietary patterns assessed via self-report. Self-reported tools have well-recognized limitations. Plasma biomarkers have been a mainstay of epidemiologic studies. Recent advances in metabolomics technology have similarly fostered discovery of metabolites that are highly specific to intakes of foods or food groups. Metabolomics offers a tangible opportunity to identify novel metabolomic signatures for a range of foods and nutrients. However, this progress relies on the tremendous need for controlled feeding studies to identify and validate metabolites specific to each food item and group.

This research will identify objective biomarkers of dietary intake that can serve as independent markers of dietary intake and complement current dietary intake assessment methods. The knowledge gained in this approach will thus address a critical gap with immediate benefits to the larger nutrition research community, both in observational and clinical trial settings, to improve the validity of major public health research initiatives. The Intervention Core, will perform tightly controlled pharmacokinetic (PK) and dose-response (DR) feeding studies across a range of food items and food groups in diverse populations. The investigators will focus on common foods from the protein, carbohydrates, and dairy food groups: (1) chicken, beef, salmon, and soybeans;(2) yogurt, cheese; and (3) whole wheat bread, potatoes, corn, and oats.

Pharmacokinetic (PK): Each participant will complete a sequence of dietary intakes of up to 8 test foods in a randomized, crossover study, blinded according to the order of randomization. In each of the eight feeding cycles a control diet is provided for a 2 day run-in, after which each participant will be given a pre-specified amount of the test foods, i.e., beef, potatoes, chicken, whole wheat bread, corn, cheese, yogurt, or oats. Blood and urine samples will be taken at time zero, every hour for blood or two hours for urine after eating, over 10 hours, and at 24 hours for untargeted Liquid chromatography-mass spectrometry (LC-MS) metabolomic analysis.

Dose Response (DR):The DR study is an isocaloric, controlled feeding study that will examine three dose levels for 10 foods in five pairings. A total of 100 eligible adults (20 per food group pairing) (will be assigned to beef/potatoes, chicken/whole wheat bread, salmon/corn, cheese/soybeans, or yogurt/oats within a standard diet at zero, medium, and high doses for six days each in a randomized crossover design. ;

Related Conditions & MeSH terms

• Biological Markers
• Diet, Healthy
• Metabolomics

• NCT number: NCT05616585
• Study type: Interventional
• Source: Harvard School of Public Health (HSPH)
• Contact: Frank M Sacks, MD
• Phone: 617-432-1420
• Email: fsacks@hsph.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Completion date: June 2025