- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405494
Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety
Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety: a Response-surface-model Study
Study Overview
Status
Intervention / Treatment
Detailed Description
It is not known how the liquid and gas volumes of a liquid foam contribute to its satiating properties and how and if these factors interact. The best way to assess these parameter combinations and their interactions is to use a special statistical approach named "Response Surface Methodology" (RSM). The current study therefore has a Central Composite Design with 9 foams differing in liquid volume and in ratio of gas to liquid volume (%overrun, which is defined as 100 x gas volume/liquid volume).
Each subject will be appointed to a single parameter combination and receives this parameter combination twice, separated by a one-week wash-out period.
On both test days subjects' self-assessment of feelings of satiety and physical discomfort will be recorded during 4 hours post-consumption of the treatment using Electronic Visual Analogue Scale.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Surrey
-
Leatherhead, Surrey, United Kingdom
- Leatherhead Food Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI between 21 and 32 kg/m²
- Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders
- Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian.
- Reported intense sporting activities below 10h/w
- Reported alcohol consumption below 14 units/w (female volunteers) or below 21 units/w (male volunteers)
Exclusion Criteria:
- Dislike, allergy or intolerance to test products or indicating to be unable to consume 514 ml of aerated test product
- Any food allergy, or dislike or intolerance with the foods supplied during the study
- Eating disorder (measured by SCOFF questionnaire, 2 or more"yes" responses) High or very high restrained eaters (measured by questionnaire; score of 15 or higher, Polivy et al. 1978)
- Reported medical treatment that may affect eating habits/satiety
- Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 6 months ago) or wish to become pregnant during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Beverage 1
Liquid foam consisting of 37 ml liquid with 73% overrun (total volume 65 ml).
|
|
|
Other: Beverage 2
Liquid foam consisting of 37 ml liquid with 427% overrun (total volume 197 ml).
|
|
|
Other: Beverage 3
Liquid foam consisting of 98 ml liquid with 73% overrun (total volume 169 ml).
|
|
|
Other: Beverage 4
Liquid foam consisting of 98 ml liquid with 427% overrun (total volume 514 ml).
|
|
|
Other: Beverage 5
Liquid foam consisting of 25 ml liquid with 250% overrun (total volume 88 ml).
|
|
|
Other: Beverage 6
Liquid foam consisting of 110 ml liquid with 250% overrun (total volume 385 ml).
|
|
|
Other: Beverage 7
68 ml beverage consisting of 68 ml liquid with 0% overrun (total volume 68 ml).
|
|
|
Other: Beverage 8
Liquid foam consisting of 68 ml liquid with 500% overrun (total volume 405 ml).
|
|
|
Other: Beverage 9
Liquid foam consisting of 68 ml liquid with 250% overrun (total volume 236 ml).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger and satiety questions (Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
Time Frame: 245 minutes
|
Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
|
245 minutes
|
Collaborators and Investigators
Sponsor
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
- 10029V
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.
Clinical Trials on Satiety
-
San Diego State UniversityRecruiting
-
San Diego State UniversityRecruiting
-
University of MinnesotaNestléCompleted
-
Pennington Biomedical Research CenterAmerican Egg BoardCompleted
-
University of LiverpoolTerminatedSatiation, SatietyUnited Kingdom
-
KU LeuvenCompletedGlucose Homeostasis | Metabolism | Intestinal Absorption | Satiety Hormones | Short-chain Fatty Acids | Satiety and AppetiteBelgium
-
San Diego State UniversityRecruiting
-
PepsiCo Global R&DCompleted
-
University of AberdeenCompleted
-
Frank GreenwayPepsiCo Global R&D; Quaker Oats CompanyCompletedFood Intake | SatietyUnited States
Clinical Trials on Beverage 1
-
Ocean Spray Cranberries, Inc.Biofortis Innovation ServicesRecruiting
-
Unilever R&DEurofins OptimedCompleted
-
Lund UniversitySwedish Foundation for Strategic ResearchCompleted
-
Mead Johnson NutritionCompleted
-
Burdur Mehmet Akif Ersoy UniversityNot yet recruitingExercise | Anthocyanins | Muscle SizeTurkey
-
PepsiCo Global R&DRecruiting
-
PepsiCo Global R&DRecruitingFluid BalanceUnited States
-
University of Arkansas, FayettevilleCompleted
-
Wageningen UniversityCompleted
-
University of CopenhagenCarlsberg Breweries A/SCompletedInsulin Resistance | Alcohol ConsumptionDenmark