Effect of Food Form on Satiety and Gastric Emptying

Appetite Clinical Trial

Official title:

Beverages and Obesity: Effect of Food Form on Satiety and Hunger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102907
• Other study ID #: 1003M78873
• Status: Completed
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite

Intervention

Other:
• Liquid Breakfast
The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk
• Solid Breakfast Meal
The solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar.

Locations

Country	Name	City	State
United States	University of Minnesota	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.	Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them.	May 2010 to December 2010
Secondary	Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled.	Subjects will consume both liquid and solid meals and we will evaluate and compare appetite and food intake after each of them.	May 2010 to December 2010