Effect of Food Form on Satiety and Gastric Emptying

NCT ID: NCT01102907

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-09-30

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.

Conditions

Appetite

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Liquid Meal

Liquid Breakfast

Intervention Type: OTHER

The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk

Solid Meal

Solid Breakfast Meal

Intervention Type: OTHER

The solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar.

Interventions

Liquid Breakfast

The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly J Willis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

1003M78873

Identifier Type: -

Identifier Source: org_study_id