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Effect of Food Form on Satiety and Gastric Emptying

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102907
First Posted: April 13, 2010
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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

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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 12, 2010
First Posted: April 13, 2010
Last Update Posted: March 29, 2012
Last Verified: March 2012

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