AppetiteNCT07600281
Ultra-Processed Foods, Palatability, Appetite, and Gastrointestinal Transit
A study testing Palatable Ultra-Processed Food Meal, Unpalatable Ultra-Processed Food Meal and Palatable Non-Ultra-Processed Food Meal in people with Appetite and Gastrointestinal Transit, run by Purdue University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how food processing level affects appetite and gastrointestinal transit time when meal palatability is changed. Participants will complete one screening visit and four test visits. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite, Gastrointestinal Transit, Food Processing
- What is being tested?
- Palatable Ultra-Processed Food Meal, Unpalatable Ultra-Processed Food Meal and Palatable Non-Ultra-Processed Food Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 18 to 60 years.
- Any sex, gender, or orientation.
- Self-reported good health.
- No medication use.
- No allergies or food sensitivities to any of the foods used in the study.
- No anticipated change in physical activity during the study period.
Show all 9Show fewer
- Willingness to complete all planned study activities, including the screening visit and four test visits.
- At screening, participants must rate the selected high-palatability foods between 60 and 90 on a 100-unit visual analog scale, where 100 = extremely palatable.
- At screening, participants must rate the selected low-palatability foods between 10 and 40 on a 100-unit visual analog scale.
Who cannot join
- Younger than 18 years or older than 60 years.
- Current medication use.
- Allergies or food sensitivities to any study foods.
- Not meeting the required palatability rating ranges during screening.
- Anticipated change in physical activity during the study period.
- Not self-reporting good health.
- Unwillingness or inability to complete the planned study activities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-Processed Foods - Palatability and Appetite
The goal of this clinical trial is to learn how food processing level affects appetite and gastrointestinal transit time when meal palatability is changed. Participants will complete one screening visit and four test visits. During each test visit, participants will consume one of four meals that differ by food processing level and palatability: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, or low-palatability non-ultra-processed food. The main questions this study aims to answer are whether food processing and palatability affect appetite sensations and gastrointestinal transit time. Participants will rate appetite sensations during each test visit and provide breath samples to measure gastrointestinal transit time.
Read the detailed description
This is a randomized crossover trial examining the effects of food processing level and palatability on appetite and gastrointestinal transit time. Participants will complete a screening visit followed by four test visits, with each test visit separated by at least one week. Each participant will consume all four test meals: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, and low-palatability non-ultra-processed food. Palatability will be reduced by adding bitter melon powder to the low-palatability meals. During each test visit, participants will consume the assigned test meal containing lactulose as a marker of gastrointestinal transit time. Breath samples will be collected to assess orocecal transit time using hydrogen analysis. Participants will also rate meal palatability and appetite sensations, including hunger, fullness, desire to eat, amount they could eat, and thirst, using visual analog scales during the test visit.
- Being tested
- Palatable Ultra-Processed Food Meal, Unpalatable Ultra-Processed Food Meal, Palatable Non-Ultra-Processed Food Meal, Unpalatable Non-Ultra-Processed Food Meal
- Keywords
- Ultra-processed foods, Non-ultra-processed foods, Palatability, Appetite, Gastrointestinal transit time, Orocecal transit time, Hydrogen breath test, Lactulose, Visual analog scale, Bitter melon powder
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatable Ultra-Processed Food MealOther
Participants will consume a palatable ultra-processed test meal during one study visit. The meal will consist of commonly available ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
Unpalatable Ultra-Processed Food MealOther
Participants will consume an unpalatable ultra-processed test meal during one study visit. Palatability will be reduced by adding organic bitter melon powder to the ultra-processed meal. The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
Palatable Non-Ultra-Processed Food MealOther
Participants will consume a palatable non-ultra-processed test meal during one study visit. The meal will consist of commonly available non-ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
Unpalatable Non-Ultra-Processed Food MealOther
Participants will consume an unpalatable non-ultra-processed test meal during one study visit. Palatability will be reduced by adding organic bitter melon powder to the non-ultra-processed meal. The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time.
| Study group | Role | What they receive |
|---|---|---|
| Palatable Ultra-Processed Food | Experimental | Participants will consume a palatable ultra-processed test meal during one study visit. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. Receives: Other: Palatable Ultra-Processed Food Meal |
| Unpalatable Ultra-Processed Food | Experimental | Participants will consume an unpalatable ultra-processed test meal during one study visit. Palatability will be reduced by adding bitter melon powder. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. Receives: Other: Unpalatable Ultra-Processed Food Meal |
| Palatable Non-Ultra-Processed Food | Experimental | Participants will consume a palatable non-ultra-processed test meal during one study visit. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. Receives: Other: Palatable Non-Ultra-Processed Food Meal |
| Unpalatable Non-Ultra-Processed Food | Experimental | Participants will consume a unpalatable non-ultra-processed test meal during one study visit. Palatability will be reduced by adding bitter melon powder. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. Receives: Other: Unpalatable Non-Ultra-Processed Food Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orocecal Transit Time
Orocecal transit time will be assessed using hydrogen analysis of end-alveolar breath samples collected after consumption of each test meal. Each test meal will contain lactulose as a marker of gastrointestinal transit time.
Measured: During each test visit, up to 4.5 hours after meal consumption
Appetite Sensations
Appetite sensations, including hunger, fullness, desire to eat, prospective food consumption, and thirst, will be assessed using 100-mm visual analog scales during each test visit after consumption of the assigned test meal every 30 minutes. Each visual analog scale ranges from 0 to 100 mm, with higher scores indicating a greater intensity of the rated sensation. Higher scores are not inherently better or worse outcomes, but reflect greater hunger, fullness, desire to eat, prospective food consumption, or thirst, depending on the item.
Measured: During each test visit, up to 4.5 hours after meal consumption
Meal Palatability Ratings
Meal palatability will be assessed using a 100-mm general labeled magnitude scale during each study visit. The scale ranges from 0 to 100 mm, with 0 mm anchored by "most disliked sensation imaginable," 50 mm anchored by "neutral," and 100 mm anchored by "most liked sensation imaginable." Higher scores indicate greater liking of the test meal and therefore a more favorable palatability rating.
Measured: During each test visit, up to 4.5 hours after meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start24 Sep 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppetiteStudies of the same condition, open and under way.
- 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
- Model description
- This is a within-subject crossover trial. Each participant will complete four test visits and consume each of the four test meals: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, and low-palatability non-ultra-processed food. Test visits will be separated by at least one week.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600281
- Sponsor's protocol ID
- IRB-2024-450
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the current IRB-approved protocol does not include a formal plan for external individual participant data sharing. Study data will be de-identified for analysis, and identifying information will be stored separately from study data. Code numbers linking participants to their data will be destroyed according to the approved protocol. No information by which participants can be identified will be released or published.
Publications
Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
PubMed 31105044
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Processed Foods - Palatability and Appetite
- ClinicalTrials.gov ID
- NCT07600281
- Acronym / sponsor ID
- IRB-2024-450
- Keywords
- Ultra-processed foods, Non-ultra-processed foods, Palatability, Appetite, Gastrointestinal transit time, Orocecal transit time, Hydrogen breath test, Lactulose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 20 May 2026 (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.
The goal of this clinical trial is to learn how food processing level affects appetite and gastrointestinal transit time when meal palatability is changed. Participants will complete one screening visit and four test visits. During each test visit, participants will consume one of four meals that differ by food processing level and palatability: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, or low-palatability non-ultra-processed food. The main questions this study aims to answer are whether food processing and palatability affect appetite sensations and gastrointestinal transit time. Participants will rate appetite sensations during each test visit and provide breath samples to measure gastrointestinal transit time.
Detailed description
This is a randomized crossover trial examining the effects of food processing level and palatability on appetite and gastrointestinal transit time. Participants will complete a screening visit followed by four test visits, with each test visit separated by at least one week. Each participant will consume all four test meals: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, and low-palatability non-ultra-processed food. Palatability will be reduced by adding bitter melon powder to the low-palatability meals. During each test visit, participants will consume the assigned test meal containing lactulose as a marker of gastrointestinal transit time. Breath samples will be collected to assess orocecal transit time using hydrogen analysis. Participants will also rate meal palatability and appetite sensations, including hunger, fullness, desire to eat, amount they could eat, and thirst, using visual analog scales during the test visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a within-subject crossover trial. Each participant will complete four test visits and consume each of the four test meals: high-palatability ultra-processed food, low-palatability ultra-processed food, high-palatability non-ultra-processed food, and low-palatability non-ultra-processed food. Test visits will be separated by at least one week.
| Arm | Type | Receives |
|---|---|---|
| Palatable Ultra-Processed Food | Experimental | Other: Palatable Ultra-Processed Food MealParticipants will consume a palatable ultra-processed test meal during one study visit. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. |
| Unpalatable Ultra-Processed Food | Experimental | Other: Unpalatable Ultra-Processed Food MealParticipants will consume an unpalatable ultra-processed test meal during one study visit. Palatability will be reduced by adding bitter melon powder. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. |
| Palatable Non-Ultra-Processed Food | Experimental | Other: Palatable Non-Ultra-Processed Food MealParticipants will consume a palatable non-ultra-processed test meal during one study visit. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. |
| Unpalatable Non-Ultra-Processed Food | Experimental | Other: Unpalatable Non-Ultra-Processed Food MealParticipants will consume a unpalatable non-ultra-processed test meal during one study visit. Palatability will be reduced by adding bitter melon powder. The meal will be used to assess appetite sensations, palatability ratings, and gastrointestinal transit time. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Individuals aged 18 to 60 years.
- Any sex, gender, or orientation.
- Self-reported good health.
- No medication use.
- No allergies or food sensitivities to any of the foods used in the study.
Key exclusion criteria (7 listed)
- Younger than 18 years or older than 60 years.
- Current medication use.
- Allergies or food sensitivities to any study foods.
- Not meeting the required palatability rating ranges during screening.
- Anticipated change in physical activity during the study period.
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 |
|---|---|---|
| Palatable Ultra-Processed Food MealParticipants will consume a palatable ultra-processed test meal during one study visit. The meal will consist of commonly available ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time. | Other | Palatable Ultra-Processed Food |
| Unpalatable Ultra-Processed Food MealParticipants will consume an unpalatable ultra-processed test meal during one study visit. Palatability will be reduced by adding organic bitter melon powder to the ultra-processed meal. The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time. | Other | Unpalatable Ultra-Processed Food |
| Palatable Non-Ultra-Processed Food MealParticipants will consume a palatable non-ultra-processed test meal during one study visit. The meal will consist of commonly available non-ultra-processed food items and will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time. | Other | Palatable Non-Ultra-Processed Food |
| Unpalatable Non-Ultra-Processed Food MealParticipants will consume an unpalatable non-ultra-processed test meal during one study visit. Palatability will be reduced by adding organic bitter melon powder to the non-ultra-processed meal. The meal will be used to assess appetite sensations, meal palatability, and gastrointestinal transit time. | Other | Unpalatable Non-Ultra-Processed Food |
Primary outcome
Orocecal Transit Time
Time frame: During each test visit, up to 4.5 hours after meal consumption
Orocecal transit time will be assessed using hydrogen analysis of end-alveolar breath samples collected after consumption of each test meal. Each test meal will contain lactulose as a marker of gastrointestinal transit time.
Appetite Sensations
Time frame: During each test visit, up to 4.5 hours after meal consumption
Appetite sensations, including hunger, fullness, desire to eat, prospective food consumption, and thirst, will be assessed using 100-mm visual analog scales during each test visit after consumption of the assigned test meal every 30 minutes. Each visual analog scale ranges from 0 to 100 mm, with higher scores indicating a greater intensity of the rated sensation. Higher scores are not inherently better or worse outcomes, but reflect greater hunger, fullness, desire to eat, prospective food consumption, or thirst, depending on the item.
Meal Palatability Ratings
Time frame: During each test visit, up to 4.5 hours after meal consumption
Meal palatability will be assessed using a 100-mm general labeled magnitude scale during each study visit. The scale ranges from 0 to 100 mm, with 0 mm anchored by "most disliked sensation imaginable," 50 mm anchored by "neutral," and 100 mm anchored by "most liked sensation imaginable." Higher scores indicate greater liking of the test meal and therefore a more favorable palatability rating.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 31105044Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the current IRB-approved protocol does not include a formal plan for external individual participant data sharing. Study data will be de-identified for analysis, and identifying information will be stored separately from study data. Code numbers linking participants to their data will be destroyed according to the approved protocol. No information by which participants can be identified will be released or published.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatable Ultra-Processed Food Meal, Unpalatable Ultra-Processed Food Meal and Palatable Non-Ultra-Processed Food Meal in people with Appetite and Gastrointestinal Transit, run by Purdue 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orocecal Transit Time (time frame: During each test visit, up to 4.5 hours after meal consumption). 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?
On the ClinicalTrials.gov record for NCT07600281, which also lists 1 linked publication.
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 22 May 2026.