Effect of Food Form on Satiety and Gastric Emptying

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01102907
First received: April 12, 2010
Last updated: March 28, 2012
Last verified: March 2012

April 12, 2010
March 28, 2012
May 2010
September 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them.
Same as current
Complete list of historical versions of study NCT01102907 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Subjects will consume both liquid and solid meals and we will evaluate and compare appetite and food intake after each of them.
Same as current
Not Provided
Not Provided
 
Effect of Food Form on Satiety and Gastric Emptying
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

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

Appetite
  • Other: Liquid Breakfast
    The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk
  • Other: Solid Breakfast Meal
    The solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar.
  • Liquid Meal
    Intervention: Other: Liquid Breakfast
  • Solid Meal
    Intervention: Other: Solid Breakfast Meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01102907
Food Form and Satiety
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Holly J Willis, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP