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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
History of Changes
  Purpose

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.


Condition Intervention
Appetite
 Other: Liquid Breakfast
Other: Solid Breakfast Meal

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Beverages and Obesity: Effect of Food Form on Satiety and Hunger

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liquid Meal Other: Liquid Breakfast
The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk
Solid Meal 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102907

Locations
United States, Minnesota
University of Minnesota
St. Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Holly J Willis, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01102907     History of Changes
Other Study ID Numbers: Food Form and Satiety
Study First Received: April 12, 2010
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Appetite
Satiety
Gastric Emptying Time
Food Intake
Food Form

ClinicalTrials.gov processed this record on May 16, 2013