Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams

To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Satiety; Appetite
• Intervention / Treatment: Dietary supplement: Very low energy aerated beverage; Dietary supplement: Normal energy aerated beverage 1; Dietary supplement: Normal energy aerated beverage 2; Dietary supplement: Normal energy aerated beverage 3

Detailed Description

The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.

On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI between 20 and 30 kg/m² (inclusive)
• Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).

Exclusion Criteria:

• Dislike, allergy or intolerance to test products
• Eating disorder (measured by SCOFF questionnaire, > 2 "yes" responses)
• High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score > 14
• Reported medical treatment that may affect eating habits/satiety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Very low energy aerated beverage	Dietary supplement: Very low energy aerated beverage
Active Comparator: Normal energy aerated beverage 1	Dietary supplement: Normal energy aerated beverage 1
Active Comparator: Normal energy aerated beverage 2	Dietary supplement: Normal energy aerated beverage 2
Active Comparator: Normal energy aerated beverage 3	Dietary supplement: Normal energy aerated beverage 3

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 points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min

Secondary Outcome Measures

Outcome Measure	Time Frame
Electronic Visual Analogue Scale (EVAS) for liking questions	Time point 15 min

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Eurofins Optimed
• Investigators: Study Director: Isabelle Blanc, PhD, Eurofins Optimed

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Estimate): March 4, 2015
• Last Update Submitted That Met QC Criteria: February 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Satiety; Appetite; Foams
• Other Study ID Numbers: FDS-NAA-0291