Metabolomics-Driven Insights Into Ultra-Processed Foods | NCT07717970

NCT07717970

Overview

NCT ID: NCT07717970
Lead Sponsor: Brigham and Women's HospitalOTHER
Official Title: Metabolomics-Driven Insights Into Ultra-Processed Foods: Identifying High-Risk UPF Subtypes for T2D Prevention
Brief Summary: The goal of this dietary intervention study in generally healthy adults is to develop new ways to use blood samples to measure the common types of highly processed foods and beverages that people eat on a regular basis. The main aims to answer are:

What small molecules are elevated in blood after eating different types of highly processed foods and beverages consistently for 1 week?

Researchers will compare 3 different test diets with 1 control diet that does not have any highly processed foods in the same individuals to see which circulating blood markers change.

Participants will:

Complete 3 diet phases, each 2 weeks long

Receive a meal plan and study foods and beverages to follow for each 2-week phase

Come to the clinic every week for blood draws, urine samples, and stool collection kits
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Jan 2027Estimated
Primary Completion Date: Mar 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Adults, ages 20 to 65 years.

BMI 18.5 to 39.9 kg/m2.

No known food allergies, intolerances, or sensitivities (e.g., gluten, dairy, monosodium-glutamate).

Not following a restrictive diet for health, religious, or other reasons (e.g., vegetarian, vegan).

Willingness to participate and give informed consent.

Willingness to consume dietary intervention foods and beverages.

Exclusion Criteria:

BMI <18.5 or >39.9 kg/m2.

Pregnant, lactating, or planning on becoming pregnant in the next 6 months.

History of bariatric surgery.

Currently taking medications impacting appetite or body weight.

History of major chronic diseases, including cardiovascular disease, type 1 or 2 diabetes, major gastrointestinal conditions, uncontrolled hypertension (seated blood pressure systolic >140 mmHg or diastolic >90 mmHg), history of invasive cancer, current use of immunosuppressants, and other major chronic diseases and conditions affecting participation, adherence, or study endpoints.

Unwilling or unable to comply with all in person scheduled visits, dietary protocols, study protocol, and other study procedures.

Food allergies or aversions to the foods provided in the dietary interventions.

Non-English speaking.

Other members of the same household are already participating in the research study.

Planning on moving out of the Boston area in the next 6 months.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Deirdre K Tobias, ScDContact
dtobias@bwh.harvard.edu617-278-0844

Similar Studies

Participant Group/Arms

Sequence 1Experimental

Participants receive Diet A, followed by Diet B, followed by Diet C.

Other: UPF Test Diet A: Starchy, refined grains

Other: UPF Test Diet B: Meat, fish, and bread products

Other: UPF Diet C: Dairy products, including cheese and cream

Sequence 2Experimental

Participants receive Diet A, followed by Diet C, followed by Diet B.

Other: UPF Test Diet A: Starchy, refined grains

Sequence 3Experimental

Participants receive Diet B, followed by Diet A, followed by Diet C.

Other: UPF Test Diet A: Starchy, refined grains

Sequence 4Experimental

Participants receive Diet B, followed by Diet C, followed by Diet A.

Other: UPF Test Diet A: Starchy, refined grains

Sequence 5Experimental

Participants receive Diet C, followed by Diet A, followed by Diet B.

Other: UPF Test Diet A: Starchy, refined grains

Sequence 6Experimental

Participants receive Diet C, followed by Diet B, followed by Diet A.

Other: UPF Test Diet A: Starchy, refined grains