Functional Gastrointestinal DisordersNCT04722419
Responses to a Comfort Meal in Functional Dyspepsia
A study testing Probe meal in people with Functional Gastrointestinal Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. Methods. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Probe meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2021to 30 Dec 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rome IV Criteria for Functional Dyspepsia
- absence of digestive symptoms
- non-obese
Who cannot join
- history of anosmia and ageusia
- alcohol abuse
- psychological disorders
- eating disorders
- history of gastrointestinal symptoms
- prior obesity
Show all 12Show fewer
- 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 in Functional Dyspepsia
Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. Methods. Parallel studies in patients with symptoms induced by meals (fulfilling Rome IV criteria of postprandial dyspepsia) and sex- and age-matched healthy subjects. Participants 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 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (112 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Probe meal
- Keywords
- meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, functional dyspepsia
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe mealOther
The probe meal will be served in 112 Kcal portions (16 g white bread, 10 g cheese, 10 g jam, 3.25 g butter, and 50 mL orange juice) up to the level of maximal satiation.
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia | Experimental | Not described Receives: Other: Probe meal |
| Healthy subjects | Active comparator | Not described Receives: Other: Probe meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal enjoyment
Amount of meal (Kcal) consumed up to the level of maximal digestive well-being measured on a - 5 (extremely unpleasant sensation) to + 5 scale (extremely pleasant sensation).
Measured: 100 minutes
Secondary outcomes (5)
Change in digestive well-being induced by the probe meal
Change in well-being measured by 10 score scales during and after the probe meal.
Measured: 1 day
Change in fullness sensation induced by the probe meal
Change in fullness sensation measured by 10 score scales during and after the probe meal.
Measured: 1 day
Change in mood induced by the probe meal
Change in mood measured by 10 score scales during and after the probe meal.
Measured: 1 day
Change in abdominal discomfort induced by the probe meal
Change in abdominal discomfort measured by 10 score scales during and after the probe meal.
Measured: 1 day
Change in hunger/satiety induced by the probe meal
Change in hunger/satiety measured by 10 score scales during and after the probe 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 posted25 Jan 2021
- Study start2 Feb 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722419
- Sponsor's protocol ID
- PR(AG)338/2016L
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.
PubMed 32252402
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT04722419
- Acronym / sponsor ID
- PR(AG)338/2016L
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, functional dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Jan 2021 (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.
Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. Methods. Parallel studies in patients with symptoms induced by meals (fulfilling Rome IV criteria of postprandial dyspepsia) and sex- and age-matched healthy subjects. Participants 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 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (112 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia | Experimental | Other: Probe meal |
| Healthy subjects | Active comparator | Other: Probe meal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rome IV Criteria for Functional Dyspepsia
- absence of digestive symptoms
- non-obese
Key exclusion criteria (12 listed)
- history of anosmia and ageusia
- alcohol abuse
- psychological disorders
- eating disorders
- history of gastrointestinal symptoms
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 |
|---|---|---|
| Probe mealThe probe meal will be served in 112 Kcal portions (16 g white bread, 10 g cheese, 10 g jam, 3.25 g butter, and 50 mL orange juice) up to the level of maximal satiation. | Other | Functional dyspepsia, Healthy subjects |
Primary outcome
Meal enjoyment
Time frame: 100 minutes
Amount of meal (Kcal) consumed up to the level of maximal digestive well-being measured on a - 5 (extremely unpleasant sensation) to + 5 scale (extremely pleasant sensation).
5 secondary outcomes
Change in digestive well-being induced by the probe meal
Time frame: 1 day
Change in fullness sensation induced by the probe meal
Time frame: 1 day
Change in mood induced by the probe meal
Time frame: 1 day
Change in abdominal discomfort induced by the probe meal
Time frame: 1 day
Change in hunger/satiety induced by the probe 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 8 Feb 2022.
- Results publication: PubMed 32252402Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.
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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 Probe meal in people with Functional Gastrointestinal Disorders, 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 3 inclusion and 12 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 8 Feb 2022. 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 enjoyment (time frame: 100 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722419, which also lists 1 linked publication.
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 8 Feb 2022.