Metabolomics-Driven Insights Into Ultra-Processed Foods

NCT07717970 | Not Yet Recruiting

• 2 other identifiers: 2026P0018701R01DK145733-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Diet, Food and Nutrition

Keywords

feeding trial; dietary intervention; ultra-processed foods; metabolomics; crossover trial

Outcome Measures

Primary Outcomes (1)

• Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet.

  The primary outcome for this study is within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet. Metabolomic responses will be quantified from metabolite concentrations (e.g., relative abundance) measured in fasting plasma samples collected at day 0, day 7, and day 14 in each diet phase.

  Day 0, Day 7, and Day 14 of each dietary intervention period

Study Arms (6)

Sequence 1

EXPERIMENTAL

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 2

EXPERIMENTAL

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

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 3

EXPERIMENTAL

Participants receive Diet B, followed by Diet A, 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 4

EXPERIMENTAL

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

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 5

EXPERIMENTAL

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

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 6

EXPERIMENTAL

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

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

Interventions

UPF Test Diet A: Starchy, refined grains OTHER

The 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with \~60% of calories from UPFs consistently of starchy foods and refined grain products. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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

The 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with \~60% of calories from UPFs consisting of dairy products, including cheese and cream. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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

The 2-week diet phase includes a standardized control run-in diet with non-UPFs only for 7 days, immediately followed by a 7-day UPF test diet with \~60% of calories from UPFs consisting of meat, fish, and bread products. Participants receive all study-provided meals and snacks. The diets are standardized and consumed during the assigned intervention period as part of the randomized crossover feeding trial.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Broad Institute of MIT and Harvard: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hopital Center for Clinical Investigation

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

In Situ Hybridization, Fluorescence

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization

Study Officials

• Deirdre K Tobias, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Shilpa Bhupathiraju, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Frank B Hu, MD PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deirdre K Tobias, ScD

CONTACT

617-278-0844; dtobias@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Epidemiologist

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date.
• Access Criteria: A Controlled Access Repository: Requests for data are reviewed by an access committee per established policies and procedures; providers may establish data use restrictions; the access period is limited; a data user's institution must sign a DUA that is similar to an NIH DUC or FDP DTUA template; data users may need to produce a data security plan.

Locations

US (1)