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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2011

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).

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Very low energy aerated beverage
    • Very low energy aerated beverage
  • Active Comparator: Normal energy aerated beverage 1
    • Normal energy aerated beverage 1
  • Active Comparator: Normal energy aerated beverage 2
    • Normal energy aerated beverage 2
  • Active Comparator: Normal energy aerated beverage 3
    • Normal energy aerated beverage 3

Clinical Trial Outcome Measures

Primary Measures

  • Hunger and satiety questions
    • Time Frame: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min
    • Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)

Secondary Measures

  • Electronic Visual Analogue Scale (EVAS) for liking questions
    • Time Frame: Time point 15 min

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Unilever R&D
  • Collaborator
    • Eurofins Optimed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Isabelle Blanc, PhD, Study Director, Eurofins Optimed

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