- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554162
Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study consists of a satiety trial and mastication trial. The satiety trial consists of five study visits. Five cereal products with berry soup are presented in random order for each subject serving one of them in each study visit (crossover study design). Each meal consists of rye product or wheat bread providing 190 kcal of energy and of 3 dl berry soup (3 dl) providing 140 kcal of energy. The participants are instructed to evaluate their satiety and related sensations before eating the test food, right after eating and then every 30 min until 210 min after breakfast consumption. The evaluated sensations are hunger, fullness, satiety, desire to eat and prospective food consumption ("How much would you be able to eat right now?"), "thirstiness", "mood", "vigourosness" and "pleasantness"."Pleasantness" will be evaluated only right after eating the test food.
Cereal food samples with 3-digit number codes will be offered to each participant in a random order in mastication trial. The study products are rye products with varying structures. First the participant is asked to evaluate the expected satiety of the product (How filling would you expect this portion to be on a scale from 0 (=not full at all) to 10 (=extremely full)). Secondly the same food will be served to the participant in three portions and the participant will be asked to masticate each portion until she considers it to be ready for swallowing. Instead of swallowing the bolus will be expectorated to a plastic container which is kept on ice. The mastication process is characterized by measuring electrical activity of facial muscles by electromyography (EMG). The mastication process will be video-recorded to support data handling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Espoo, Finland
- Aalto University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI 18.5-25 kg/m2
- Habit of eating breakfast
Exclusion Criteria:
- Significant changes in body weight (+ or - 4 kg) during the previous year
- Smoking
- Pregnant or lactating
- Missing teeth (except 3rd molars)
- Acute temporomandibular disorders (TMD)
- Dietary restrictions possibly affecting the study (celiac disease, allergies or aversions to cereal foods/high carbohydrate foods)
- Abnormal eating behaviour (according to EDDS (Eating Disorder Diagnostic Scale))
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 |
---|---|
Active Comparator: Extruded wholegrain rye flakes
Rye products with varying structures
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The satiating effect of rye products with various structures will be studied
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Active Comparator: Extruded wholegrain rye puffs
Rye products with varying structures
|
The satiating effect of rye products with various structures will be studied
|
Active Comparator: Fresh wholegrain rye bread
Rye products with varying structures
|
The satiating effect of rye products with various structures will be studied
|
Active Comparator: Wholegrain rye beverage
Rye products with varying structures
|
The satiating effect of rye products with various structures will be studied
|
Active Comparator: Fresh wheat bread
Rye products with varying structures
|
The satiating effect of rye products with various structures will be studied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postprandial satiety, assessed using 10 cm visual analogue scale (0=not at all, 10=Extremely)
Time Frame: In every 30 min until 210 min after consumption
|
In every 30 min until 210 min after consumption
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Chewy
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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