Effects of Ultra Processed Food on Intestinal Energy Harvest (UPFEH)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity and Overweight
• Intervention / Treatment: Behavioral: Diet containing 80% ultra processed foods; Behavioral: Diet containing 20% ultra processed foods

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faris M Zuraikat, PhD; Phone Number: 212 305 9379; Email: fmz2105@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Faris M Zuraikat, PhD
      • Principal Investigator: Faris M Zuraikat, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 80% Ultra processed; Participants will be provided with shopping lists and menus for the two arms of the diet intervention.	Behavioral: Diet containing 80% ultra processed foods; Very high ultra-processed food diet where 80% of calories are coming from ultra processed food
Experimental: 20% Ultra processed; Participants will be provided with shopping lists and menus for the two arms of the diet intervention.	Behavioral: Diet containing 20% ultra processed foods; Low ultra processed food diet where 20% of the calories are coming from ultra processed food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal energy loss	Amount of calories absorbed from diet will be the difference from energy intake - calories in stool	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial taxa	Change in types of microbial taxa from baseline to end of diet period	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin, glucose, serum lipid and lipoproteins (mg/dl)	Bloods drawn at each timepoint will be assayed for overlapping metabolic markers	2 weeks
C-peptide (ng/ml)	Bloods drawn at each timepoint will be assayed for overlapping metabolic markers	2 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: UNC Gillings School of Global Public Health
• Investigators: Principal Investigator: Faris M Zuraikat, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Energy balance; Ultra processed Food
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Food, Processed
• Other Study ID Numbers: AAAV3549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Stool samples
• IPD Sharing Time Frame: March 8, 2025 - March 8, 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No