AppetiteNCT01102907
Effect of Food Form on Satiety and Gastric Emptying
An observational study of Appetite, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Liquid Breakfast and Solid Breakfast Meal
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2010
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: Beverages and Obesity: Effect of Food Form on Satiety and Hunger
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.
- Conditions
- Appetite
- Being tested
- Liquid Breakfast, Solid Breakfast Meal
- Keywords
- Appetite, Satiety, Gastric Emptying Time, Food Intake, Food Form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid BreakfastOther
The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk
Solid Breakfast MealOther
The solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar.
| Study group | Role | What they receive |
|---|---|---|
| Liquid Meal | Not described Receives: Other: Liquid Breakfast | |
| Solid Meal | Not described Receives: Other: Solid Breakfast Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.
Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them.
Measured: May 2010 to December 2010
Secondary outcomes (1)
Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled.
Subjects will consume both liquid and solid meals and we will evaluate and compare appetite and food intake after each of them.
Measured: May 2010 to December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly J Willis, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102907
- Sponsor's protocol ID
- 1003M78873
- Status last verified
- Oct 2019
- First submitted
- 12 Apr 2010
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beverages and Obesity: Effect of Food Form on Satiety and Hunger
- ClinicalTrials.gov ID
- NCT01102907
- Acronym / sponsor ID
- 1003M78873
- Conditions
- Appetite
- Keywords
- Appetite, Satiety, Gastric Emptying Time, Food Intake, Food Form
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Apr 2010 (estimated)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid Meal | – | Other: Liquid Breakfast |
| Solid Meal | – | Other: Solid Breakfast Meal |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (8 listed)
- Healthy women
- Age 18 - 35
- Body mass index in the healthy range between 18.5 and 25
- Proficient English speakers
- Non-smoking
Key exclusion criteria (18 listed)
- 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)
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 |
|---|---|---|
| Liquid BreakfastThe liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk | Other | Liquid Meal |
| Solid Breakfast MealThe solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar. | Other | Solid Meal |
Primary outcome
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.
Time frame: May 2010 to December 2010
Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them.
1 secondary outcome
Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled.
Time frame: May 2010 to December 2010
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 1 Nov 2019.
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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.
Holly J Willis, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetite, run by University of Minnesota 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 8 inclusion and 18 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 1 Nov 2019. 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?
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled. (time frame: May 2010 to December 2010). 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 1 Nov 2019.