Tiny study to test how Ultra-Processed foods affect weight and health
NCT ID NCT07318064
First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 4 times
Summary
This pilot study will compare two diets—one high in ultra-processed foods and one typical American diet—in 6 adults with overweight or obesity. Participants will try each diet for two weeks in random order. The goal is not to prove which diet is better, but to see if a larger study is possible and to estimate how many people would be needed for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dietary intervention (ultra-processed food diet vs. typical American diet)
- What this could lead to
- If successful, this pilot could provide the necessary data to design a larger trial that may clarify how ultra-processed foods affect health.
- What could go wrong
- This is a very small pilot study with only 6 participants and a short 2-week diet period, so results may not apply to the general population or show clear health effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Overweight or obesity (BMI 25-50 kg/m2) * Willingness to accept group assignment and provide outcome measures * Premenopausal (women only) * Be able to communicate (oral and written) in English * Be able to provide informed consent Exclusion Criteria: * Recent weight loss (≥10 pounds in the last six months) * On a regimen of medications (weight loss or otherwise) that can affect weight or diabetes outcomes for less than 3 months (GLP1 medications allowed if weight stable and on stable dose for \>=3 months) * Given birth within the past year or is currently pregnant or breastfeeding * Past bariatric surgery (\<10 years) - all types * Disease/condition that is life threatening or can interfere with or be aggravated by weight change * Dementia, psychiatric illness, or substance abuse that may interfere with adherence * Current or history of a clinically diagnosed eating disorder, including anorexia nervosa or bulimia nervosa * Type 1 or type 2 diabetes * Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease * Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Exceptions include 1) successfully resected non-melanoma carcinoma of the skin, 2) basal or squamous cell skin cancer, 3) stage 0 non-invasive carcinoma of the cervix, 4) stage 0 non-invasive prostate cancer * History of kidney or liver disease or malnutrition that in investigator judgment should exclude participation * Hemoglobinopathy that interferes with measurement of HbA1c * Class II or higher congestive heart failure * Unstable heart disease * Blood pressure ≥160/100 mm Hg * Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 weeks. * Unwilling to stop alcohol intake during study participation * Current smoker or other type of tobacco user (chewing tobacco, vaping, etc.) * Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70810, United States
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