HealthyNCT03134365
Palatability and Postprandial Sensations
A study testing Mixed meal and Combined meal in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mixed meal and Combined meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 4 Aug 2016to 2 Dec 2016
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non obese
Who cannot join
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors to Determine the Responses to Meal Ingestion: Palatability
Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days.
Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.
- Conditions
- Healthy
- Being tested
- Mixed meal, Combined meal
- Keywords
- meal ingestion, palatability, postprandial responses, hedonic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed mealOther
Mixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability.
Combined mealOther
Combined meal.
| Study group | Role | What they receive |
|---|---|---|
| Mixed meal | Experimental | Not described Receives: Other: Mixed meal |
| Combined meal | Active comparator | Not described Receives: Other: Combined meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal palatability
Meal palatability measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in digestive well-being measured after the test meal
Change in average well-being measured by 10 score scales at the end of the test meal.
Measured: 1 day
Secondary outcomes (4)
Change in satiety measured after the test meal
Change in average satiety measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in fullness sensation measured after the test meal
Change in average fullness measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in abdominal discomfort/pain sensation measured after the test meal
Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in mood measured after the test meal
Change in average mood measured by 10 score scales at the end of the test meal.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start4 Aug 2016
- Primary completion23 Nov 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134365
- Sponsor's protocol ID
- PR(AG)338/2016C
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors to Determine the Responses to Meal Ingestion: Palatability
- ClinicalTrials.gov ID
- NCT03134365
- Acronym / sponsor ID
- PR(AG)338/2016C
- Conditions
- Healthy
- Keywords
- meal ingestion, palatability, postprandial responses, hedonic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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.
Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days.
Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed meal | Experimental | Other: Mixed meal |
| Combined meal | Active comparator | Other: Combined meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non obese
Key exclusion criteria (8 listed)
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
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 |
|---|---|---|
| Mixed mealMixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability. | Other | Mixed meal |
| Combined mealCombined meal. | Other | Combined meal |
Primary outcome
Meal palatability
Time frame: 1 day
Meal palatability measured by 10 score scales at the end of the test meal
Change in digestive well-being measured after the test meal
Time frame: 1 day
Change in average well-being measured by 10 score scales at the end of the test meal.
4 secondary outcomes
Change in satiety measured after the test meal
Time frame: 1 day
Change in fullness sensation measured after the test meal
Time frame: 1 day
Change in abdominal discomfort/pain sensation measured after the test meal
Time frame: 1 day
Change in mood measured after the test meal
Time frame: 1 day
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 28 Apr 2017.
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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 Mixed meal and Combined meal in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 1 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 28 Apr 2017. 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 Spain. 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?
Meal palatability (time frame: 1 day). The study lists 2 primary outcomes in all. 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 28 Apr 2017.