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Effects of Ultra Processed Food on Intestinal Energy Harvest

Effects of Ultra Processed Food on Intestinal Energy Harvest

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06853288
Acronym
UPFEH
Enrollment
20
Registered
2025-02-28
Start date
2025-03-30
Completion date
2026-12-31
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and Overweight

Keywords

Obesity, Ultra processed Food, Energy balance

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.

Interventions

BEHAVIORALDiet containing 80% ultra processed foods

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

BEHAVIORALDiet containing 20% ultra processed foods

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

Sponsors

UNC Gillings School of Global Public Health
CollaboratorUNKNOWN
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fecal energy loss2 weeksAmount of calories absorbed from diet will be the difference from energy intake - calories in stool

Secondary

MeasureTime frameDescription
Microbial taxa2 weeksChange in types of microbial taxa from baseline to end of diet period

Other

MeasureTime frameDescription
Insulin, glucose, serum lipid and lipoproteins (mg/dl)2 weeksBloods drawn at each timepoint will be assayed for overlapping metabolic markers
C-peptide (ng/ml)2 weeksBloods drawn at each timepoint will be assayed for overlapping metabolic markers

Countries

United States

Contacts

Primary ContactFaris M Zuraikat, PhD
fmz2105@cumc.columbia.edu212 305 9379

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026