Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

NCT ID: NCT04691882

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2021-01-22

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Diaphragmatic contraction

Group Type EXPERIMENTAL

Diaphragmatic contraction

Intervention Type BEHAVIORAL

Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion

Diaphragmatic relaxation

Group Type ACTIVE_COMPARATOR

Diaphagmatic relaxation

Intervention Type BEHAVIORAL

Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion

Interventions

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Diaphragmatic contraction

Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion

Intervention Type BEHAVIORAL

Diaphagmatic relaxation

Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* non-obese

Exclusion Criteria

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.

Reference Type RESULT
PMID: 32252402 (View on PubMed)

Livovsky 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.

Reference Type DERIVED
PMID: 33670508 (View on PubMed)

Other Identifiers

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PR(AG)338/2016K

Identifier Type: -

Identifier Source: org_study_id

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