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

Appetite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379312
• Other study ID #: FDS-NAA-0291
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: February 26, 2015
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Appetite
• Satiety

Intervention

Dietary Supplement:
• Very low energy aerated beverage

• Normal energy aerated beverage 1

• Normal energy aerated beverage 2

• Normal energy aerated beverage 3

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Eurofins Optimed

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)	Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min	No
Secondary	Electronic Visual Analogue Scale (EVAS) for liking questions		Time point 15 min	No