SatietyNCT02379312
Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
A study testing Very low energy aerated beverage, Normal energy aerated beverage 1 and Normal energy aerated beverage 2 in people with Satiety and Appetite, run by Unilever R&D.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Very low energy aerated beverage, Normal energy aerated beverage 1 and Normal energy aerated beverage 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Dec 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 20 and 30 kg/m² (inclusive)
- Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
Who cannot join
- 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
About this study
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.
Read the 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).
- Being tested
- Very low energy aerated beverage, Normal energy aerated beverage 1, Normal energy aerated beverage 2, Normal energy aerated beverage 3
- Keywords
- Foams, Satiety, Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low energy aerated beverageDietary supplement
Normal energy aerated beverage 1Dietary supplement
Normal energy aerated beverage 2Dietary supplement
Normal energy aerated beverage 3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Very low energy aerated beverage | Active comparator | Very low energy aerated beverage Receives: Dietary Supplement: Very low energy aerated beverage |
| Normal energy aerated beverage 1 | Active comparator | Normal energy aerated beverage 1 Receives: Dietary Supplement: Normal energy aerated beverage 1 |
| Normal energy aerated beverage 2 | Active comparator | Normal energy aerated beverage 2 Receives: Dietary Supplement: Normal energy aerated beverage 2 |
| Normal energy aerated beverage 3 | Active comparator | Normal energy aerated beverage 3 Receives: Dietary Supplement: Normal energy aerated beverage 3 |
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)
Measured: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min
Secondary outcomes (1)
Electronic Visual Analogue Scale (EVAS) for liking questions
Measured: Time point 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Responsible party
- Sponsor
- Investigators
- Isabelle Blanc, PhD, Study director, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379312
- Sponsor's protocol ID
- FDS-NAA-0291
- Status last verified
- Jan 2015
- First submitted
- 17 Feb 2015
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
- ClinicalTrials.gov ID
- NCT02379312
- Acronym / sponsor ID
- FDS-NAA-0291
- Keywords
- Foams, Satiety, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Mar 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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Very low energy aerated beverage | Active comparator | Dietary Supplement: Very low energy aerated beverageVery low energy aerated beverage |
| Normal energy aerated beverage 1 | Active comparator | Dietary Supplement: Normal energy aerated beverage 1Normal energy aerated beverage 1 |
| Normal energy aerated beverage 2 | Active comparator | Dietary Supplement: Normal energy aerated beverage 2Normal energy aerated beverage 2 |
| Normal energy aerated beverage 3 | Active comparator | Dietary Supplement: Normal energy aerated beverage 3Normal energy aerated beverage 3 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 20 and 30 kg/m² (inclusive)
- Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Very low energy aerated beverage | Dietary supplement | Very low energy aerated beverage |
| Normal energy aerated beverage 1 | Dietary supplement | Normal energy aerated beverage 1 |
| Normal energy aerated beverage 2 | Dietary supplement | Normal energy aerated beverage 2 |
| Normal energy aerated beverage 3 | Dietary supplement | Normal energy aerated beverage 3 |
Primary outcome
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)
1 secondary outcome
Electronic Visual Analogue Scale (EVAS) for liking questions
Time frame: Time point 15 min
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 4 Mar 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.
Isabelle Blanc, PhD study director
Eurofins Optimed
Questions about this trial
What is this clinical trial studying?
A study testing Very low energy aerated beverage, Normal energy aerated beverage 1 and Normal energy aerated beverage 2 in people with Satiety and Appetite, run by Unilever R&D.
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 2 inclusion and 4 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min). 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 4 Mar 2015.