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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02379312
Enrollment
72
Registered
2015-03-04
Start date
2011-10-31
Completion date
2011-12-31
Last updated
2015-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetite, Satiety

Keywords

Foams, Satiety, Appetite

Brief 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.

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_SUPPLEMENTVery low energy aerated beverage
DIETARY_SUPPLEMENTNormal energy aerated beverage 1
DIETARY_SUPPLEMENTNormal energy aerated beverage 2
DIETARY_SUPPLEMENTNormal energy aerated beverage 3

Sponsors

Eurofins Optimed
CollaboratorINDUSTRY
Unilever R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hunger and satiety questionsTime points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 minArea under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)

Secondary

MeasureTime frame
Electronic Visual Analogue Scale (EVAS) for liking questionsTime point 15 min

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026