Ultra-Processed Foods for Diet and Nutrition

DK
Overseen ByDeirdre K Tobias, ScD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

FB

Frank B Hu, MD PhD

Principal Investigator

Harvard School of Public Health (HSPH)

DK

Deirdre K Tobias, ScD

Principal Investigator

Brigham and Women's Hospital

SB

Shilpa Bhupathiraju, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Willingness to participate and give informed consent
I am willing to eat and drink the study foods and beverages.
BMI 18.5 to 39.9 kg/m2
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Exclusion Criteria

BMI less than 18.5 or greater than 39.9 kg/m2
Pregnant, lactating, or planning on becoming pregnant in the next 6 months
Unwilling or unable to comply with all in person scheduled visits, dietary protocols, study protocol, and other study procedures
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Sequence 6Experimental Treatment3 Interventions
Group II: Sequence 5Experimental Treatment3 Interventions
Group III: Sequence 4Experimental Treatment3 Interventions
Group IV: Sequence 3Experimental Treatment3 Interventions
Group V: Sequence 2Experimental Treatment3 Interventions
Group VI: Sequence 1Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Broad Institute of MIT and Harvard

Collaborator

Trials
21
Recruited
16,300+

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

Collaborator

Trials
2,513
Recruited
4,366,000+