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Effect of Abdominal Wall Activity on the Responses to Meal Ingestion

V

Vall d'Hebron University Hospital (HUVH)

Status

Completed

Conditions

Healthy

Treatments

Behavioral: Diaphragmatic contraction
Behavioral: Diaphagmatic relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT04691882
PR(AG)338/2016K

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Diaphragmatic contraction
Experimental group
Treatment:
Behavioral: Diaphragmatic contraction
Diaphragmatic relaxation
Active Comparator group
Treatment:
Behavioral: Diaphagmatic relaxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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