Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety

Appetite Clinical Trial

Official title:

Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety: a Response-surface-model Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405494
• Other study ID #: 10029V
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: April 9, 2015
• Start date: February 2011
• Est. completion date: February 2011

Study information

• Verified date: April 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: Ethics committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite
• Satiety

Intervention

Dietary Supplement:
• Beverage 1

• Beverage 2

• Beverage 3

• Beverage 4

• Beverage 5

• Beverage 6

• Beverage 7

• Beverage 8

• Beverage 9

Locations

Country	Name	City	State
United Kingdom	Leatherhead Food Research	Leatherhead	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hunger and satiety questions (Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)	Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)	245 minutes	No