Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

NCT04691882 | Completed

• 1 other identifier: PR(AG)338/2016K
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; abdominal wall activity; abdominal distension

Outcome Measures

Primary Outcomes (1)

• Changes in abdominal fullness/bloating sensation induced by the probe meal

  Effect of abdominal wall activity on abdominal fullness/bloating \[measured by 10 cm scale graded from 0 (not at all) to 10 (very much)\]

  10 min

Secondary Outcomes (1)

• Changes in digestive well-being sensation induced by the probe meal

  10 min

Study Arms (2)

Diaphragmatic contraction

EXPERIMENTAL

Behavioral: Diaphragmatic contraction

Diaphragmatic relaxation

ACTIVE COMPARATOR

Behavioral: Diaphagmatic relaxation

Interventions

Diaphragmatic contraction BEHAVIORAL

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

Diaphragmatic contraction

Diaphagmatic relaxation BEHAVIORAL

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

Diaphragmatic relaxation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-obese

You may not qualify if:

• history of gastrointestinal symptoms
• prior obesity
• use of medications
• history of anosmia and ageusia
• current dieting
• alcohol abuse
• psychological disorders
• eating disorders

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (2)

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

  PMID: 32252402 RESULT

• 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.

  PMID: 33670508 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: October 12, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 22, 2021
• Last Updated: February 18, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)