Healthy SubjectsNCT02097927
The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures
A study testing Mango-flavour beverage in people with Healthy Subjects, run by Leatherhead Food Research at 1 site in United Kingdom.
Trial summary
The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Mango-flavour beverage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Aug 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: male or female
- Age at start of the study ≥ 18 and ≤ 65 years
- Body Mass Index (BMI) ≥ 18 and ≤ 29.9 kg/m2
- Apparently healthy: measured by questionnaire (APPENDIX 3): no reported current or previous metabolic diseases or chronic gastrointestinal disorders
- Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
- Reported intense sporting activities ≤ 10h/w
Show all 9Show fewer
- Reported alcohol consumption ≤14 units/w
- Informed consent signed
- Recruitment form filled out
Who cannot join
- Smoking
- Dislike, allergy or intolerance to test products or study meals
- Possible eating disorder (measured by SCOFF questionnaire score >1)
- Reported medical treatment that may affect eating habits/satiety
- Eating habits questionnaire score >14
- Reported participation in another biomedical trial 1 month before the start of the study
- Food allergies or intolerance to ad libitum meals
- Pregnant and/or breast feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leatherhead Food Research Nutrition Unit
Leatherhead, Surrey, KT22 7RY
About this study
The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control.
In addition, saliva samples will be collected at regular intervals for the identification of novel biomarkers of energy intake.
Read the detailed description
The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions (plus one screening visit) before and after repeated exposures to the beverages at home. The order in which participants receive the beverages will be counterbalanced and randomised. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations. Participants will fast overnight before each visit and consume the same evening meal before each test day. Participants will be instructed to avoid consuming food or calorific beverages for one hour before or after consuming the beverage. Following the last satiety testing day participants will be debriefed and open questions will be asked about experiences of the beverages in a focus group format.
- Conditions
- Healthy Subjects
- Being tested
- Mango-flavour beverage
- Keywords
- Appetite, Satiety, Energy intake, Saliva, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango-flavour beverageBehavioural
The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions before and after repeated exposures to the beverages at home. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations.
| Study group | Role | What they receive |
|---|---|---|
| High energy, low sensory | Experimental | Mango-flavour beverage Receives: Behavioral: Mango-flavour beverage |
| Low energy, high sensory | Experimental | Mango-flavour beverage Receives: Behavioral: Mango-flavour beverage |
| High energy, high sensory beverage | Experimental | Mango-flavour beverage Receives: Behavioral: Mango-flavour beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy intake
Change in intake (kcals) at an ad libitum lunch, assessed before and after the repeated exposure period for each of the 3 beverage products
Measured: Weeks 0,3,5,8,10 and 13
Secondary outcomes (1)
Change in subjective appetite ratings
Change in subjective feelings of appetite assessed with Visual Analogue Scales (VAS). These will be measured on each of the 6 test days, which will occur before and after the repeated exposure period for each of the 3 beverage products.
Measured: Weeks 0,3,5,8,10 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leatherhead Food Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Sussex
- Responsible party
- Sponsor
- Investigators
- Roberta Re, PhD, Study director, Leatherhead Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097927
- Sponsor's protocol ID
- 127438-1
- Status last verified
- Aug 2014
- First submitted
- 19 Mar 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures
- ClinicalTrials.gov ID
- NCT02097927
- Acronym / sponsor ID
- 127438-1
- Conditions
- Healthy Subjects
- Keywords
- Appetite, Satiety, Energy intake, Saliva, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Leatherhead Food ResearchIndustry (pharma, biotech, devices)
- Collaborators
- University of Sussex
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Mar 2014 (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.
The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control.
In addition, saliva samples will be collected at regular intervals for the identification of novel biomarkers of energy intake.
Detailed description
The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions (plus one screening visit) before and after repeated exposures to the beverages at home. The order in which participants receive the beverages will be counterbalanced and randomised. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations. Participants will fast overnight before each visit and consume the same evening meal before each test day. Participants will be instructed to avoid consuming food or calorific beverages for one hour before or after consuming the beverage. Following the last satiety testing day participants will be debriefed and open questions will be asked about experiences of the beverages in a focus group format.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High energy, low sensory | Experimental | Behavioral: Mango-flavour beverageMango-flavour beverage |
| Low energy, high sensory | Experimental | Behavioral: Mango-flavour beverageMango-flavour beverage |
| High energy, high sensory beverage | Experimental | Behavioral: Mango-flavour beverageMango-flavour beverage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gender: male or female
- Age at start of the study ≥ 18 and ≤ 65 years
- Body Mass Index (BMI) ≥ 18 and ≤ 29.9 kg/m2
- Apparently healthy: measured by questionnaire (APPENDIX 3): no reported current or previous metabolic diseases or chronic gastrointestinal disorders
- Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
Key exclusion criteria (8 listed)
- Smoking
- Dislike, allergy or intolerance to test products or study meals
- Possible eating disorder (measured by SCOFF questionnaire score >1)
- Reported medical treatment that may affect eating habits/satiety
- Eating habits questionnaire score >14
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 |
|---|---|---|
| Mango-flavour beverageThe study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions before and after repeated exposures to the beverages at home. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations. | Behavioural | High energy, high sensory beverage, High energy, low sensory, Low energy, high sensory |
Primary outcome
Change in energy intake
Time frame: Weeks 0,3,5,8,10 and 13
Change in intake (kcals) at an ad libitum lunch, assessed before and after the repeated exposure period for each of the 3 beverage products
1 secondary outcome
Change in subjective appetite ratings
Time frame: Weeks 0,3,5,8,10 and 13
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 7 Aug 2014.
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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.
Roberta Re, PhD study director
Leatherhead Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango-flavour beverage in people with Healthy Subjects, run by Leatherhead Food Research 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 9 inclusion and 8 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 7 Aug 2014. 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?
Change in energy intake (time frame: Weeks 0,3,5,8,10 and 13). 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 7 Aug 2014.