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 — OTHERThe 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 — OTHERThe 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 — OTHERThe 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 1Participants receive Diet A, followed by Diet B, followed by Diet C.
- Experimental: Sequence 2Participants receive Diet A, followed by Diet C, followed by Diet B.
- Experimental: Sequence 3Participants receive Diet B, followed by Diet A, followed by Diet C.
- Experimental: Sequence 4Participants receive Diet B, followed by Diet C, followed by Diet A.
- Experimental: Sequence 5Participants receive Diet C, followed by Diet A, followed by Diet B.
- Experimental: Sequence 6Participants 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
- Deirdre K Tobias, ScD617-278-0844
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hopital Center for Clinical Investigation | Boston | Massachusetts | 02115 |
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