Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT06853288

Conditions

Obesity and Overweight

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Diet containing 80% ultra processed foods

Diet containing 20% ultra processed foods

Study Details

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

Study ID

NCT06853288

Start date

Mar 30, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 80% Ultra processed

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

experimental: 20% Ultra processed

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

Interventions

Diet containing 80% ultra processed foods

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

Diet containing 20% ultra processed foods

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

Primary outcome measure

  • Fecal energy loss [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Faris M Zuraikat, PhD

More Information

Sponsor

Columbia University

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Keywords

  • Obesity
  • Ultra processed Food
  • Energy balance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-10-03.