Effect of Food Form on Satiety and Gastric Emptying

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01102907
Collaborator
(none)
10
1
4
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Liquid Breakfast
  • Other: Solid Breakfast Meal

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Beverages and Obesity: Effect of Food Form on Satiety and Hunger
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled. [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

  1. Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled. [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.

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 University of Minnesota Saint Paul Minnesota United States 55108

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Holly J Willis, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT01102907
Other Study ID Numbers:
  • 1003M78873
First Posted:
Apr 13, 2010
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Keywords provided by University of Minnesota

Study Results

No Results Posted as of Nov 1, 2019