Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04691882

Collaborator

(none)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Diaphragmatic contraction Behavioral: Diaphagmatic relaxation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Factors That Determine the Responses to Meal Ingestion: Effect of Abdominal Wall Activity

Actual Study Start Date :

Oct 12, 2020

Actual Primary Completion Date :

Jan 15, 2021

Actual Study Completion Date :

Jan 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diaphragmatic contraction	Behavioral: Diaphragmatic contraction Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion
Active Comparator: Diaphragmatic relaxation	Behavioral: Diaphagmatic relaxation Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion

Arm

Intervention/Treatment

Experimental: Diaphragmatic contraction

Behavioral: Diaphragmatic contraction

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

Active Comparator: Diaphragmatic relaxation

Behavioral: Diaphagmatic relaxation

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

Outcome Measures

Primary Outcome Measures

Changes in abdominal fullness/bloating sensation induced by the probe meal [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)]

Secondary Outcome Measures

Changes in digestive well-being sensation induced by the probe meal [10 min]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT04691882

Other Study ID Numbers:

PR(AG)338/2016K

First Posted:

Dec 31, 2020

Last Update Posted:

Feb 18, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

meal ingestion

postprandial responses

hedonic sensations

homeostatic sensations

abdominal wall activity

abdominal distension

Study Results

No Results Posted as of Feb 18, 2021