Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691882
• Other study ID #: PR(AG)338/2016K
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: December 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 22, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Diaphragmatic contraction
Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion
• Diaphagmatic relaxation
Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4). pii: E986. doi: 10.3390/nu12040986. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in digestive well-being sensation induced by the probe meal	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)]	10 min