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Metabolomics-Driven Insights Into Ultra-Processed Foods

ConditionDiet, Food and Nutrition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorBrigham and Women's Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • UPF Test Diet A: Starchy, refined grains

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

40 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Sequence 1Experimental treatment 3 interventions
Group B: Sequence 2Experimental treatment 3 interventions
Group C: Sequence 3Experimental treatment 3 interventions
Group D: Sequence 4Experimental treatment 3 interventions
Group E: Sequence 5Experimental treatment 3 interventions
Group F: Sequence 6Experimental treatment 3 interventions

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Broad Institute of MIT and Harvard

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: