- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02070185
Effect of Energy Density on Liking and on Caloric Adjustment Conditioning
Effect of Energy Density on Liking and on Caloric Adjustment Conditioning After Sweet Beverage Exposure in Children Aged 8-11 y
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bourgogne
-
Dijon, Bourgogne, France, 21000
- Centre des Sciences du Goût et de l'Alimentation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- regularly ate at the school canteen
- returned signed consent from parents
Exclusion Criteria:
- present health problems, food restrictions or food allergies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2 exposures
During the conditioning period, the children of this group was exposed only twice to the beverages
|
During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal). During a 4-wk conditioning period, children were exposed either 2 times to each beverage. After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period). |
Experimental: 7 exposures
During the conditioning period, children of this group were exposed exposed 7 times to the beverages
|
During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal). During a 4-wk conditioning period, children were exposed either 7 times to each beverage. After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flavored beverages liking and preference before the conditioning period (T0)
Time Frame: Baseline
|
Liking and preference measurements for the flavored beverages, before the conditioning period.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy adjustment before the conditioning period (T0)
Time Frame: Baseline
|
Measure of energy intake at the lunch following the beverage consumption, before the conditioning period
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy adjustment after the conditioning period (T1)
Time Frame: T0 + 4 weeks
|
Measure of energy intake at the lunch following the beverage consumption, after the 4-week conditioning period
|
T0 + 4 weeks
|
Flavored beverages liking and preference after the conditioning period (T1)
Time Frame: T0 + 4 weeks
|
Liking and preference measurements for the new flavored beverages, after the 4-week conditioning period.
|
T0 + 4 weeks
|
Flavored beverages liking and preference after 3 weeks without exposure (T2)
Time Frame: T1 + 3 weeks
|
liking and preference measurements of the new flavored beverages, after a period of 3 weeks without exposure (=stability period)
|
T1 + 3 weeks
|
Flavored beverages liking and preference before the extinction period (T3)
Time Frame: T2 +1 week
|
Liking and preference measurements of the new flavored beverages before a 4-week- extinction period during which the energy density of the beverages were changed
|
T2 +1 week
|
Energy adjustment before an extinction period (T3)
Time Frame: T2 + 1 week
|
Measure of energy intake at the lunch following the beverages consumption,before the 4-week- extinction period, during which the energy density of the beverages were changed.
|
T2 + 1 week
|
Energy adjustment after 3 weeks without exposure (T2)
Time Frame: T1 + 3 weeks
|
Measure of energy intake at lunch following the beverage consumption, after a period of 3 weeks without exposure
|
T1 + 3 weeks
|
Energy adjustment after the extinction period (T4)
Time Frame: T3 + 4 weeks
|
Measure of energy intake at the lunch following the beverages consumption,after the 4-week- extinction period, during which the energy density of the beverages were changed.
|
T3 + 4 weeks
|
Flavored beverages liking and preference before the extinction period (T4)
Time Frame: T3 + 4 weeks
|
Liking and preference measurements of the new flavored beverages after the 4-week- extinction period during which the energy density of the beverages were changed
|
T3 + 4 weeks
|
Collaborators and Investigators
Publications and helpful links
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
Other Study ID Numbers
- Energy
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