HealthyNCT03084276
Effect of Meal Composition on the Responses to Meal Ingestion
A study testing High-fat meal and Low-fat meal in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture… 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?
- High-fat meal and Low-fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2017to 21 Mar 2017
- 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 That Determine the Responses to Meal Ingestion: Meal Composition
Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 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 3 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
- High-fat meal, Low-fat meal
- Keywords
- meal ingestion, meal composition, postprandial responses, hedonic sensations, homeostatic sensations, new composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat mealOther
High-fat meal
Low-fat mealOther
Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.
| Study group | Role | What they receive |
|---|---|---|
| High-fat meal | Experimental | Not described Receives: Other: High-fat meal |
| Low-fat meal | Active comparator | Not described Receives: Other: Low-fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 posted20 Mar 2017
- Study start16 Jan 2017
- Primary completion17 Mar 2017
- Study completion21 Mar 2017
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084276
- Sponsor's protocol ID
- PR(AG)338/2016B
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 25 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 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Determine the Responses to Meal Ingestion: Meal Composition
- ClinicalTrials.gov ID
- NCT03084276
- Acronym / sponsor ID
- PR(AG)338/2016B
- Conditions
- Healthy
- Keywords
- meal ingestion, meal composition, postprandial responses, hedonic sensations, homeostatic sensations, new composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 20 Mar 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 to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 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 3 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-fat meal | Experimental | Other: High-fat meal |
| Low-fat meal | Active comparator | Other: Low-fat 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 |
|---|---|---|
| High-fat mealHigh-fat meal | Other | High-fat meal |
| Low-fat mealLow-fat meal with the same physical and organoleptic characteristics as the high-calorie meal. | Other | Low-fat meal |
Primary outcome
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 25 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 High-fat meal and Low-fat 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 25 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?
Change in digestive well-being measured after the test meal (time frame: 1 day). 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 25 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.