SatietyNCT02405494
Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety
A study testing Beverage 1, Beverage 2 and Beverage 3 in people with Satiety and Appetite, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Beverage 1, Beverage 2 and Beverage 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety: a Response-surface-model Study
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.
Read the detailed description
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.
- Being tested
- Beverage 1, Beverage 2, Beverage 3, Beverage 4, Beverage 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage 1Dietary supplement
Beverage 2Dietary supplement
Beverage 3Dietary supplement
Beverage 4Dietary supplement
Beverage 5Dietary supplement
Beverage 6Dietary supplement
Beverage 7Dietary supplement
Beverage 8Dietary supplement
Beverage 9Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Beverage 1 | Other | Liquid foam consisting of 37 ml liquid with 73% overrun (total volume 65 ml). Receives: Dietary Supplement: Beverage 1 |
| Beverage 2 | Other | Liquid foam consisting of 37 ml liquid with 427% overrun (total volume 197 ml). Receives: Dietary Supplement: Beverage 2 |
| Beverage 3 | Other | Liquid foam consisting of 98 ml liquid with 73% overrun (total volume 169 ml). Receives: Dietary Supplement: Beverage 3 |
| Beverage 4 | Other | Liquid foam consisting of 98 ml liquid with 427% overrun (total volume 514 ml). Receives: Dietary Supplement: Beverage 4 |
| Beverage 5 | Other | Liquid foam consisting of 25 ml liquid with 250% overrun (total volume 88 ml). Receives: Dietary Supplement: Beverage 5 |
| Beverage 6 | Other | Liquid foam consisting of 110 ml liquid with 250% overrun (total volume 385 ml). Receives: Dietary Supplement: Beverage 6 |
| Beverage 7 | Other | 68 ml beverage consisting of 68 ml liquid with 0% overrun (total volume 68 ml). Receives: Dietary Supplement: Beverage 7 |
| Beverage 8 | Other | Liquid foam consisting of 68 ml liquid with 500% overrun (total volume 405 ml). Receives: Dietary Supplement: Beverage 8 |
| Beverage 9 | Other | Liquid foam consisting of 68 ml liquid with 250% overrun (total volume 236 ml). Receives: Dietary Supplement: Beverage 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger and satiety questions (Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
Measured: 245 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405494
- Sponsor's protocol ID
- 10029V
- Status last verified
- Apr 2015
- First submitted
- 12 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety: a Response-surface-model Study
- ClinicalTrials.gov ID
- NCT02405494
- Acronym / sponsor ID
- 10029V
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Beverage 1 | Other | Dietary Supplement: Beverage 1Liquid foam consisting of 37 ml liquid with 73% overrun (total volume 65 ml). |
| Beverage 2 | Other | Dietary Supplement: Beverage 2Liquid foam consisting of 37 ml liquid with 427% overrun (total volume 197 ml). |
| Beverage 3 | Other | Dietary Supplement: Beverage 3Liquid foam consisting of 98 ml liquid with 73% overrun (total volume 169 ml). |
| Beverage 4 | Other | Dietary Supplement: Beverage 4Liquid foam consisting of 98 ml liquid with 427% overrun (total volume 514 ml). |
| Beverage 5 | Other | Dietary Supplement: Beverage 5Liquid foam consisting of 25 ml liquid with 250% overrun (total volume 88 ml). |
| Beverage 6 | Other | Dietary Supplement: Beverage 6Liquid foam consisting of 110 ml liquid with 250% overrun (total volume 385 ml). |
| Beverage 7 | Other | Dietary Supplement: Beverage 768 ml beverage consisting of 68 ml liquid with 0% overrun (total volume 68 ml). |
| Beverage 8 | Other | Dietary Supplement: Beverage 8Liquid foam consisting of 68 ml liquid with 500% overrun (total volume 405 ml). |
| Beverage 9 | Other | Dietary Supplement: Beverage 9Liquid foam consisting of 68 ml liquid with 250% overrun (total volume 236 ml). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beverage 1 | Dietary supplement | Beverage 1 |
| Beverage 2 | Dietary supplement | Beverage 2 |
| Beverage 3 | Dietary supplement | Beverage 3 |
| Beverage 4 | Dietary supplement | Beverage 4 |
| Beverage 5 | Dietary supplement | Beverage 5 |
| Beverage 6 | Dietary supplement | Beverage 6 |
| Beverage 7 | Dietary supplement | Beverage 7 |
| Beverage 8 | Dietary supplement | Beverage 8 |
| Beverage 9 | Dietary supplement | Beverage 9 |
Primary outcome
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 frame: 245 minutes
Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage 1, Beverage 2 and Beverage 3 in people with Satiety and Appetite, run by Unilever R&D at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: 245 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.