NCT04691882

Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Diaphragmatic contraction	Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion
BEHAVIORAL	Diaphagmatic relaxation	Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion

Timeline

• Start date: 2020-10-12
• Primary completion: 2021-01-15
• Completion: 2021-01-22
• First posted: 2020-12-31
• Last updated: 2021-02-18

Locations

1 site across 1 country: Spain