Obesity and OverweightUPFEHNCT06853288
Effects of Ultra Processed Food on Intestinal Energy Harvest
A study testing Diet containing 80% ultra processed foods and Diet containing 20% ultra processed foods in people with Obesity and Overweight, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Diet containing 80% ultra processed foods and Diet containing 20% ultra processed foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- history of or planned bariatric surgery
- history of anti obesity medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Faris M Zuraikat, PhD
Faris M Zuraikat, PhD
About this study
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.
Read the 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.
- Conditions
- Obesity and Overweight
- Being tested
- Diet containing 80% ultra processed foods, Diet containing 20% ultra processed foods
- Keywords
- Obesity, Ultra processed Food, Energy balance
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet containing 80% ultra processed foodsBehavioural
Very high ultra-processed food diet where 80% of calories are coming from ultra processed food
Diet containing 20% ultra processed foodsBehavioural
Low ultra processed food diet where 20% of the calories are coming from ultra processed food
| Study group | Role | What they receive |
|---|---|---|
| 80% Ultra processed | Experimental | Participants will be provided with shopping lists and menus for the two arms of the diet intervention. Receives: 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. Receives: Behavioral: Diet containing 20% ultra processed foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal energy loss
Amount of calories absorbed from diet will be the difference from energy intake - calories in stool
Measured: 2 weeks
Resting Energy Expenditure
Energy expenditure at rest, derived from whole-room calorimetry
Measured: 2 weeks
Body composition
Lean and fat mass quantified from QMR
Measured: 2 weeks
Secondary outcomes (1)
Microbial taxa
Change in types of microbial taxa from baseline to end of diet period
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start30 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- UNC Gillings School of Global Public Health
- Responsible party
- Principal investigator, Faris M Zuraikat, PhD, Columbia University
- Investigators
- Faris M Zuraikat, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853288
- Sponsor's protocol ID
- AAAV3549
- Acronym
- UPFEH
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Stool samples
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultra Processed Food on Intestinal Energy Harvest
- ClinicalTrials.gov ID
- NCT06853288
- Acronym / sponsor ID
- UPFEH / AAAV3549
- Conditions
- Obesity and Overweight
- Keywords
- Obesity, Ultra processed Food, Energy balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- UNC Gillings School of Global Public Health
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80% Ultra processed | Experimental | Behavioral: Diet containing 80% ultra processed foodsParticipants will be provided with shopping lists and menus for the two arms of the diet intervention. |
| 20% Ultra processed | Experimental | Behavioral: Diet containing 20% ultra processed foodsParticipants will be provided with shopping lists and menus for the two arms of the diet intervention. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- history of or planned bariatric surgery
- history of anti obesity medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet containing 80% ultra processed foodsVery high ultra-processed food diet where 80% of calories are coming from ultra processed food | Behavioural | 80% Ultra processed |
| Diet containing 20% ultra processed foodsLow ultra processed food diet where 20% of the calories are coming from ultra processed food | Behavioural | 20% Ultra processed |
Primary outcome
Fecal energy loss
Time frame: 2 weeks
Amount of calories absorbed from diet will be the difference from energy intake - calories in stool
Resting Energy Expenditure
Time frame: 2 weeks
Energy expenditure at rest, derived from whole-room calorimetry
Body composition
Time frame: 2 weeks
Lean and fat mass quantified from QMR
1 secondary outcome
Microbial taxa
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Stool samples
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faris M Zuraikat, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet containing 80% ultra processed foods and Diet containing 20% ultra processed foods in people with Obesity and Overweight, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faris M Zuraikat, PhD (212 305 9379, fmz2105@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal energy loss (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.