Appetite, Eating Behavior, Food Palatability, Food Processing, Gastrointestinal Transit
Conditions
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
Brief 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. 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.
Interventions
OTHERPalatable Ultra-Processed Food Meal
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.
OTHERUnpalatable Ultra-Processed Food Meal
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.
OTHERPalatable Non-Ultra-Processed Food Meal
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.
OTHERUnpalatable Non-Ultra-Processed Food Meal
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.
Sponsors
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orocecal Transit Time | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed