Effects of Ultra Processed Food on Intestinal Energy Harvest

NCT ID: NCT06853288

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2026-12-31

Brief Summary

Ultra processed food is everywhere in modern society and may contain multiple ingredients that affect the way participants' bodies store energy. Some studies have shown that eating a diet high in ultra processed foods leads to weight gain, but these foods have not been studied enough to understand why. Recently, the gut microbiome has become a potential way to measure energy balance in the human body; this is done by measuring how many calories are in the stool. The investigators propose to test a very high ultra-processed food diet where 80% of calories are coming from ultra processed food and a low ultra processed food diet where 20% of the calories are coming from ultra processed food. This study will compare stool sample energy content of the two diets.

Detailed Description

This study will recruit people with obesity who are otherwise healthy to participate in this study. Each person will go through baseline testing before starting any of the diets. This consists of one blood draw, one metabolic test which requires each person to remain awake in a small, enclosed room that measures oxygen and carbon dioxide consumption, and one body composition test. Participants will also meet with a study dietitian to review their diet, how to track their diet, and how to collect and ship the stool samples. Each person will be assigned to either 80% or 20% level of ultra processed food in the diet to start and will continue this diet for two weeks. After the first diet phase, each participant will enter a washout period where they will return to eating however they wish and will not need to participate in any research activities. After the two weeks, each participant will return to begin another series of tests and begin the second two-week diet phase. The whole study will take approximately 9 weeks to complete.

Conditions

Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

80% Ultra processed

Participants will be provided with shopping lists and menus for the two arms of the diet intervention.

Group Type: EXPERIMENTAL

Diet containing 80% ultra processed foods

Intervention Type: BEHAVIORAL

Very high ultra-processed food diet where 80% of calories are coming from ultra processed food

20% Ultra processed

Participants will be provided with shopping lists and menus for the two arms of the diet intervention.

Group Type: EXPERIMENTAL

Diet containing 20% ultra processed foods

Intervention Type: BEHAVIORAL

Low ultra processed food diet where 20% of the calories are coming from ultra processed food

Interventions

Diet containing 80% ultra processed foods

Very high ultra-processed food diet where 80% of calories are coming from ultra processed food

Intervention Type: BEHAVIORAL

Diet containing 20% ultra processed foods

Low ultra processed food diet where 20% of the calories are coming from ultra processed food

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI 30-40kg/m2
• weight stable
• able to download app and willing to use it for duration of study
• does own grocery shopping
• otherwise healthy

Exclusion Criteria

• pregnancy
• history of or planned bariatric surgery
• history of anti obesity medications

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Gillings School of Global Public Health

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Faris M Zuraikat, PhD

Assistant Professor of Nutritional Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faris M Zuraikat, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Faris M Zuraikat, PhD

Role: CONTACT

fmz2105@cumc.columbia.edu

212 305 9379

Facility Contacts

Faris M Zuraikat, PhD

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAV3549

Identifier Type: -

Identifier Source: org_study_id