Effect of Food Form on Satiety and Gastric Emptying

Completed

• Conditions: Appetite
• Interventions: Other: Solid Breakfast Meal; Other: Liquid Breakfast

• Registration Number: NCT01102907
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Study Start: 2010-05
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid Meal	Solid Breakfast Meal	-
Liquid Meal	Liquid Breakfast	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Saint Paul, Minnesota, United States