Effects of Ultra Processed Food on Intestinal Energy Harvest

NCT06853288 | Recruiting

• 1 other identifier: AAAV3549
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Overweight

Keywords

Obesity; Ultra processed Food; Energy balance

Outcome Measures

Primary Outcomes (1)

• Fecal energy loss

  Amount of calories absorbed from diet will be the difference from energy intake - calories in stool

  2 weeks

Secondary Outcomes (1)

• Microbial taxa

  2 weeks

Other Outcomes (2)

• Insulin, glucose, serum lipid and lipoproteins (mg/dl)

  2 weeks

• C-peptide (ng/ml)

  2 weeks

Study Arms (2)

80% Ultra processed

EXPERIMENTAL

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

Behavioral: Diet containing 80% ultra processed foods

20% Ultra processed

EXPERIMENTAL

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

Behavioral: Diet containing 20% ultra processed foods

Interventions

Diet containing 80% ultra processed foods BEHAVIORAL

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

80% Ultra processed

Diet containing 20% ultra processed foods BEHAVIORAL

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

20% Ultra processed

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• UNC Gillings School of Global Public Health: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Food, Processed

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Faris M Zuraikat, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faris M Zuraikat, PhD

CONTACT

212 305 9379; fmz2105@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nutritional Medicine

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: March 8, 2025 - March 8, 2026

Locations

US (1)