Metabolomics-Driven Insights Into Ultra-Processed Foods

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07717970
Status
Not Yet Recruiting

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Conditions

  • Diet, Food and Nutrition

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • 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.

Study Details

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

Key Dates

First listed
Jul 21, 2026
Start date
Jan 31, 2027
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Sequence 1
    Participants receive Diet A, followed by Diet B, followed by Diet C.
  • Experimental: Sequence 2
    Participants receive Diet A, followed by Diet C, followed by Diet B.
  • Experimental: Sequence 3
    Participants receive Diet B, followed by Diet A, followed by Diet C.
  • Experimental: Sequence 4
    Participants receive Diet B, followed by Diet C, followed by Diet A.
  • Experimental: Sequence 5
    Participants receive Diet C, followed by Diet A, followed by Diet B.
  • Experimental: Sequence 6
    Participants receive Diet C, followed by Diet B, followed by Diet A.

Primary Outcome Measure

Within-person metabolomic response during each UPF test diet, compared to the paired non-UPF control diet. [ Time Frame: Day 0, Day 7, and Day 14 of each dietary intervention period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's Hopital Center for Clinical InvestigationBostonMassachusetts02115
Yemi Talabi-Oates, MBA
617-732-8750

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