NCT04691882

Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

Completed NA Last updated 18 February 2021

What this trial tests

NA trial testing Diaphragmatic contraction in Healthy in 16 participants. Completed in 22 January 2021.

Timeline

12 October 2020

Primary endpoint
15 January 2021

22 January 2021

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	16
Start date	12 October 2020
Primary completion	15 January 2021
Estimated completion	22 January 2021
Sites	1 location across Spain

Drugs / interventions tested

• Diaphragmatic contraction
• Diaphagmatic relaxation

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Adults 18 to 70, female only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion.
   Livovsky DM, Barber C, Barba E, Accarino A, et al · · 2021 · cited 11× · PMID 33670508 · DOI 10.3390/nu13020658