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NCT Number: NCT06853288

Effects of Ultra Processed Food on Intestinal Energy Harvest

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.

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Key information

Conditions

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

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Faris M Zuraikat, PhD

CONTACT

Faris M Zuraikat, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet containing 80% ultra processed foods

Behavioral

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

Diet containing 20% ultra processed foods

Behavioral

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

Primary outcomes

  1. Fecal energy loss

    Time frame: 2 weeks

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

Secondary outcomes

  1. Microbial taxa

    Time frame: 2 weeks

    Change in types of microbial taxa from baseline to end of diet period

Other outcomes

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

    Time frame: 2 weeks

    Bloods drawn at each timepoint will be assayed for overlapping metabolic markers

  2. C-peptide (ng/ml)

    Time frame: 2 weeks

    Bloods drawn at each timepoint will be assayed for overlapping metabolic markers

Study contacts

Contact information is provided by the study sponsor or research team.

Faris M Zuraikat, PhD

CONTACT

[email protected]

212 305 9379

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • UNC Gillings School of Global Public Health

Registry information

Acronym: UPFEH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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