Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Diaphagmatic relaxation; Behavioral: Diaphragmatic contraction

• Registration Number: NCT04691882
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-12
• Status Verified: 2020-12
• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-22
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diaphragmatic relaxation	Diaphagmatic relaxation	-
Diaphragmatic contraction	Diaphragmatic contraction	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in digestive well-being sensation induced by the probe meal	10 min	Effect of abdominal wall activity on digestive well-being \[measured by 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely unpleasant extremely pleasant sensation)\]

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain