Effect of Food Form on Satiety and Gastric Emptying

NCT01102907 | Completed

• 1 other identifier: 1003M78873
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Appetite; Satiety; Gastric Emptying Time; Food Intake; Food Form

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (2)

Liquid Meal

Other: Liquid Breakfast

Solid Meal

Other: Solid Breakfast Meal

Interventions

Liquid Breakfast OTHER

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

Liquid Meal

Solid Breakfast Meal OTHER

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

Solid Meal

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Study Officials

• Holly J Willis, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)