Effect of Food Form on Satiety and Gastric Emptying (NCT01102907) | Clinical Trial Compass
CompletedNot Applicable
Effect of Food Form on Satiety and Gastric Emptying
United States10 participantsStarted 2010-05
Plain-language summary
Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying will be evaluated using the Smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch.
Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. We also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy women
* Age 18 - 35
* Body mass index in the healthy range between 18.5 and 25
* Proficient English speakers
* Non-smoking
* Not taking medications
* Non-dieting (weight stable over last 3 months)
* Able to swallow a large capsule
Exclusion Criteria:
* Irregular or erratic breakfast eating patterns
* Food allergies to ingredients commonly found in test products or pizza
* Distaste for test products or pizza
* BMI less than 18.5 or greater than 25
* Weight change \> 5 kg in last 3 months (intentional or unintentional)
* Difficulty swallowing
* Cardiovascular disease
* Diabetes mellitus (fasting blood sugar \> 126 mg/dl)
* Cancer in prior 5 years (except basal cell carcinoma of skin)
* Kidney or liver disease
* Any gastrointestinal conditions that may affect digestion and absorption
* Recent bacterial infection (\< 3 months)
* Chronic medication use
* History of drug or alcohol abuse in prior 6 months
* Concurrent or recent intervention study participation
* Vegetarians or people who ate more than approximately 15 g of fiber per day
* Pregnant or lactating women
* Women with irregular menstrual cycles
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.