HealthyNCT04691882
Effect of Abdominal Wall Activity on the Responses to Meal Ingestion
A study testing Diaphragmatic contraction and Diaphagmatic relaxation in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of abdominal wall activity on the responses to a standard probe meal. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diaphragmatic contraction and Diaphagmatic relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 12 Oct 2020to 22 Jan 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 70 years
- Women 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: Effect of Abdominal Wall Activity
Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of abdominal wall activity on the responses to a standard probe meal. Study in healthy subjects comparing postprandial digestive sensations (abdominal bloating and digestive well-being) during consecutive maneuvers of diaphragmatic contraction (i.e. descent) versus diaphragmatic relaxation (i.e. ascent) in a cross-over randomized design. Primary outcome: effect of somatic maneuvers on abdominal bloating sensation; secondary aim: effect on digestive well-being.
Participants (16 women) 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. Participants will be taught to produce diaphragmatic contraction and visible abdominal distention. A probe meal up to maximal satiation will be administered to induce abdominal fullness/bloating sensation; immediately after ingestion, bloating sensation (from 0 to 10) and digestive well-being (from -5 to +5) will be scored during 8 alternating episodes (30 s each) in random sequence of diaphragmatic contraction (abdominal distension) versus diaphragmatic relaxation.
- Conditions
- Healthy
- Being tested
- Diaphragmatic contraction, Diaphagmatic relaxation
- Keywords
- meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, abdominal wall activity, abdominal distension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic contractionBehavioural
Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion
Diaphagmatic relaxationBehavioural
Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic contraction | Experimental | Not described Receives: Behavioral: Diaphragmatic contraction |
| Diaphragmatic relaxation | Active comparator | Not described Receives: Behavioral: Diaphagmatic relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in abdominal fullness/bloating sensation induced by the probe meal
Effect of abdominal wall activity on abdominal fullness/bloating [measured by 10 cm scale graded from 0 (not at all) to 10 (very much)]
Measured: 10 min
Secondary outcomes (1)
Changes in digestive well-being sensation induced by the probe meal
Effect of abdominal wall activity on digestive well-being [measured by 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely unpleasant extremely pleasant sensation)]
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start12 Oct 2020
- Primary completion15 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691882
- Sponsor's protocol ID
- PR(AG)338/2016K
- Status last verified
- Dec 2020
- First submitted
- 30 Dec 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 32252402Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.
PubMed 33670508
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Determine the Responses to Meal Ingestion: Effect of Abdominal Wall Activity
- ClinicalTrials.gov ID
- NCT04691882
- Acronym / sponsor ID
- PR(AG)338/2016K
- Conditions
- Healthy
- Keywords
- meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, abdominal wall activity, abdominal distension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 31 Dec 2020 (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.
Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of abdominal wall activity on the responses to a standard probe meal. Study in healthy subjects comparing postprandial digestive sensations (abdominal bloating and digestive well-being) during consecutive maneuvers of diaphragmatic contraction (i.e. descent) versus diaphragmatic relaxation (i.e. ascent) in a cross-over randomized design. Primary outcome: effect of somatic maneuvers on abdominal bloating sensation; secondary aim: effect on digestive well-being.
Participants (16 women) 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. Participants will be taught to produce diaphragmatic contraction and visible abdominal distention. A probe meal up to maximal satiation will be administered to induce abdominal fullness/bloating sensation; immediately after ingestion, bloating sensation (from 0 to 10) and digestive well-being (from -5 to +5) will be scored during 8 alternating episodes (30 s each) in random sequence of diaphragmatic contraction (abdominal distension) versus diaphragmatic relaxation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic contraction | Experimental | Behavioral: Diaphragmatic contraction |
| Diaphragmatic relaxation | Active comparator | Behavioral: Diaphagmatic relaxation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female 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 |
|---|---|---|
| Diaphragmatic contractionSequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion | Behavioural | Diaphragmatic contraction |
| Diaphagmatic relaxationSequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion | Behavioural | Diaphragmatic relaxation |
Primary outcome
Changes in abdominal fullness/bloating sensation induced by the probe meal
Time frame: 10 min
Effect of abdominal wall activity on abdominal fullness/bloating [measured by 10 cm scale graded from 0 (not at all) to 10 (very much)]
1 secondary outcome
Changes in digestive well-being sensation induced by the probe meal
Time frame: 10 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 18 Feb 2021.
- 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.
- Derived from this study: PubMed 33670508Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.
- Individual participant dataSharing planned: No
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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 Diaphragmatic contraction and Diaphagmatic relaxation 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 18 Feb 2021. 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?
Changes in abdominal fullness/bloating sensation induced by the probe meal (time frame: 10 min). 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 NCT04691882, which also lists 2 linked publications.
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 18 Feb 2021.