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

Unilever

Status: Completed

Conditions: Satiety; Appetite

Treatments: Dietary Supplement: Very low energy aerated beverage; Dietary Supplement: Normal energy aerated beverage 2; Dietary Supplement: Normal energy aerated beverage 1; Dietary Supplement: Normal energy aerated beverage 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02379312

FDS-NAA-0291

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups

Very low energy aerated beverage

Active Comparator group

Description:

Very low energy aerated beverage

Treatment:

Dietary Supplement: Very low energy aerated beverage

Normal energy aerated beverage 1

Active Comparator group

Description:

Normal energy aerated beverage 1

Treatment:

Dietary Supplement: Normal energy aerated beverage 1

Normal energy aerated beverage 2

Active Comparator group

Description:

Normal energy aerated beverage 2

Treatment:

Dietary Supplement: Normal energy aerated beverage 2

Normal energy aerated beverage 3

Active Comparator group

Description:

Normal energy aerated beverage 3

Treatment:

Dietary Supplement: Normal energy aerated beverage 3