Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety

NCT ID: NCT02405494

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of this study is to test the individual contribution, and possible interaction, of the liquid volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x \[gas volume/liquid volume\]) of a beverage to its satiating properties.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is not known how the liquid and gas volumes of a liquid foam contribute to its satiating properties and how and if these factors interact. The best way to assess these parameter combinations and their interactions is to use a special statistical approach named "Response Surface Methodology" (RSM). The current study therefore has a Central Composite Design with 9 foams differing in liquid volume and in ratio of gas to liquid volume (%overrun, which is defined as 100 x gas volume/liquid volume).

Each subject will be appointed to a single parameter combination and receives this parameter combination twice, separated by a one-week wash-out period.

On both test days subjects' self-assessment of feelings of satiety and physical discomfort will be recorded during 4 hours post-consumption of the treatment using Electronic Visual Analogue Scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Satiety Appetite

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beverage 1

Liquid foam consisting of 37 ml liquid with 73% overrun (total volume 65 ml).

Group Type OTHER

Beverage 1

Intervention Type DIETARY_SUPPLEMENT

Beverage 2

Liquid foam consisting of 37 ml liquid with 427% overrun (total volume 197 ml).

Group Type OTHER

Beverage 2

Intervention Type DIETARY_SUPPLEMENT

Beverage 3

Liquid foam consisting of 98 ml liquid with 73% overrun (total volume 169 ml).

Group Type OTHER

Beverage 3

Intervention Type DIETARY_SUPPLEMENT

Beverage 4

Liquid foam consisting of 98 ml liquid with 427% overrun (total volume 514 ml).

Group Type OTHER

Beverage 4

Intervention Type DIETARY_SUPPLEMENT

Beverage 5

Liquid foam consisting of 25 ml liquid with 250% overrun (total volume 88 ml).

Group Type OTHER

Beverage 5

Intervention Type DIETARY_SUPPLEMENT

Beverage 6

Liquid foam consisting of 110 ml liquid with 250% overrun (total volume 385 ml).

Group Type OTHER

Beverage 6

Intervention Type DIETARY_SUPPLEMENT

Beverage 7

68 ml beverage consisting of 68 ml liquid with 0% overrun (total volume 68 ml).

Group Type OTHER

Beverage 7

Intervention Type DIETARY_SUPPLEMENT

Beverage 8

Liquid foam consisting of 68 ml liquid with 500% overrun (total volume 405 ml).

Group Type OTHER

Beverage 8

Intervention Type DIETARY_SUPPLEMENT

Beverage 9

Liquid foam consisting of 68 ml liquid with 250% overrun (total volume 236 ml).

Group Type OTHER

Beverage 9

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beverage 1

Intervention Type DIETARY_SUPPLEMENT

Beverage 2

Intervention Type DIETARY_SUPPLEMENT

Beverage 3

Intervention Type DIETARY_SUPPLEMENT

Beverage 4

Intervention Type DIETARY_SUPPLEMENT

Beverage 5

Intervention Type DIETARY_SUPPLEMENT

Beverage 6

Intervention Type DIETARY_SUPPLEMENT

Beverage 7

Intervention Type DIETARY_SUPPLEMENT

Beverage 8

Intervention Type DIETARY_SUPPLEMENT

Beverage 9

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI between 21 and 32 kg/m²
* Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian.
* Reported intense sporting activities below 10h/w
* Reported alcohol consumption below 14 units/w (female volunteers) or below 21 units/w (male volunteers)

Exclusion Criteria

* Dislike, allergy or intolerance to test products or indicating to be unable to consume 514 ml of aerated test product
* Any food allergy, or dislike or intolerance with the foods supplied during the study
* Eating disorder (measured by SCOFF questionnaire, 2 or more"yes" responses) High or very high restrained eaters (measured by questionnaire; score of 15 or higher, Polivy et al. 1978)
* Reported medical treatment that may affect eating habits/satiety
* Reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 6 months ago) or wish to become pregnant during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leatherhead Food Research

Leatherhead, Surrey, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10029V

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fizzy Drinks Study
NCT02735889 COMPLETED NA