Clinical trial NCT01102907: Effect of Food Form on Satiety and Gastric Emptying
Official title: Beverages and Obesity: Effect of Food Form on Satiety and Hunger
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appetite
Keywords: Appetite
Satiety
Gastric Emptying Time
Food Intake
Food Form
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.
timeFrame: May 2010 to December 2010
Secondary outcomes:
measure: Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled.
timeFrame: May 2010 to December 2010
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Holly J Willis, PhD
role: PRINCIPAL_INVESTIGATOR
References: