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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04691882
Enrollment
16
Registered
2020-12-31
Start date
2020-10-12
Completion date
2021-01-22
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

BEHAVIORALDiaphragmatic contraction

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

BEHAVIORALDiaphagmatic relaxation

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

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in abdominal fullness/bloating sensation induced by the probe meal10 minEffect of abdominal wall activity on abdominal fullness/bloating \[measured by 10 cm scale graded from 0 (not at all) to 10 (very much)\]

Secondary

MeasureTime frameDescription
Changes in digestive well-being sensation induced by the probe meal10 minEffect of abdominal wall activity on digestive well-being \[measured by 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely unpleasant extremely pleasant sensation)\]

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026