- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06853249
Influence of Food Texture on Appetite Control, Gastric Emptying, and Energy Expenditure
The aim of the study is to investigate the effect of liquid versus semi-solid meals on the regulation of energy balance in healthy young adults.The main questions it aims to answer are:
- Does a protein-rich liquid meal result in less satiety and therefore higher ad libitum energy intake at the next meal than an isocaloric oatmeal with the same macronutrient ratio?
- Is the consumption of a protein-rich liquid meal as a beverage in addition to an ad libitum oatmeal less compensated within the meal and at the next meal and provides thus a higher ad libitum energy intake than an isovolumetric noncaloric soft drink in addition to an ad libitum oatmeal?
Researchers will compare a protein-rich liquid meal to an isocaloric oatmeal with matched macronutrient composition to answer the first question. Researchers will compare a protein-rich liquid meal + oatmeal to a noncaloric softdrink (water with sucralose and flavoring) + oatmeal to answer the second question.
Participants will:
- spend 4 intervention days in a metabolic chamber (whole room indirect calorimeter)
- consume pre-definied preloads for breakfast and ad libitum lunch meals on 4 intervention days
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kiel, Germany
- Kiel University, Institute of Human Nutrition
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy males and females
- Body Mass Index between 19-35 kg/m2
- low to medium habitual physical activity
- women with regular menstrual cycle (during intervention in follicular phase)
Exclusion Criteria:
- smoking (cigarettes + cannabis)
- chronic illnesses
- regular intake of medication
- Anemia and/or iron deficiency
- food allergies / intolerances
- vegans
- regular high physical activity (exercise >1 hour/d)
- current weight loss diet / weight loss of >5 kg in the last 3 months
- restraint eaters (according to the German version of the 'Three-Factor-Eating-Questionnaire', Stunkard und Messick (1985))
- active participation in another trial
- pregnant / lactating women
- persons incapable of giving informed legal consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: isocaloric preload
In this arm of the study, participants receive two different isocaloric preloads for breakfast, one as a liquid meal and one as oatmeal.
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An isocaloric amount (500 kcal) of a commercially available liquid meal with a matched macronutrient composition is consumed.
After 5 hours, lunch is eaten ad libitum.
An isocaloric amount (500 kcal) of a commercially available semi-solid oatmeal with a matched macronutrient composition is consumed.
After 5 hours, lunch is eaten ad libitum.
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Experimental: ad libitum preload
In this arm of the study, participants are given two different isovolumetric drinks as a preload in addition to an ad libitum oatmeal breakfast.
One drink is a liquid meal, the other is a non-caloric soft drink (water, sucralose, flavour).
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A predefined amount of a caloric drink (= liquid meal) together with an ad libitum amount of a semi-solid meal is consumed.
After 5 hours, lunch is eaten ad libitum.
A predefined amount of a non-caloric drink (= water, sucralose, flavor) together with an ad libitum amount of a semi-solid meal is consumed.
After 5 hours, lunch is eaten ad libitum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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ad libitum energy intake
Time Frame: for 9 hours after the consumption of the preloads
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measured during preload and lunch [kcal] following the preload in both arms
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for 9 hours after the consumption of the preloads
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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gastric emptying
Time Frame: for 4 hours after the consumption of the isocaloric preloads
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gastric half-emptying time [min] determined with 13C-sodium acetate breath test, only assessed during arm "isocaloric preload"
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for 4 hours after the consumption of the isocaloric preloads
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eating rate at lunch
Time Frame: at 5 hours after consumption of the preload
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assessed during ad libitum lunch [g/min] following the preload in both arms
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at 5 hours after consumption of the preload
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number of chews per bite at lunch
Time Frame: at 5 hours after consumption of the preload
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assessed during ad libitum lunch [number] following the preload in both arms
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at 5 hours after consumption of the preload
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serum ghrelin concentrations
Time Frame: for 3 hours after consumption of the isocaloric preloads
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area under the serum ghrelin concentration curve over 3 hours
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for 3 hours after consumption of the isocaloric preloads
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serum peptide-YY (PYY) concentrations
Time Frame: for 3 hours after consumption of the isocaloric preloads
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area under the serum PYY concentration curve over 3 hours
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for 3 hours after consumption of the isocaloric preloads
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serum Glucagon-like Peptide 1 (GLP-1) concentrations
Time Frame: for 3 hours after consumption of the isocaloric preloads
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area under the serum GLP-1 concentration curve over 3 hours
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for 3 hours after consumption of the isocaloric preloads
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energy expenditure
Time Frame: measured for 9.5 hours
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Measured as kcal for 9.5 hours in a whole room indirect calorimeter (WRIC), including the consumption of the preload and the ad libitum lunch.
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measured for 9.5 hours
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macronutrient oxidation
Time Frame: measured for 9.5 hours
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Measured as respiratory exchange ratio (RER) for 9.5 hours in a whole room indirect calorimeter (WRIC), including the consumption of the preload and the ad libitum lunch.
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measured for 9.5 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anja Bosy-Westphal, PhD, MD, University of Kiel, Department of Human Nutrition
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ABW-2025-YF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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