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Completed

NCT Number: NCT01102907

Effect of Food Form on Satiety and Gastric Emptying

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.

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Key information

Conditions

Appetite

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid Breakfast

Other

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

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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