Clinical trial NCT02405494: Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety
Official title: Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety: a Response-surface-model Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Appetite
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of this study is to test the individual contribution, and possible interaction, of the liquid volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x \[gas volume/liquid volume\]) of a beverage to its satiating properties.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hunger and satiety questions (Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
timeFrame: 245 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food Research
state: Surrey
Study officials:
References: