Metabolomics-Driven Insights Into Ultra-Processed Foods

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

Interventions

OTHER

UPF Test Diet A: Starchy, refined grains

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.

OTHER

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

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.

OTHER

UPF Diet C: Dairy products, including cheese and cream

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.

Sponsors & Collaborators

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

  collaborator NIH

• Broad Institute of MIT and Harvard

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Deirdre K Tobias, ScD · Brigham and Women's Hospital

• Shilpa Bhupathiraju, PhD · Brigham and Women's Hospital

• Frank B Hu, MD PhD · Harvard School of Public Health (HSPH)

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-01-31

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• United States

Study Locations