Hospital Vall d'Hebron
Barcelona, 08035, Spain
NCT Number: NCT04691882
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.
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Notify Me18 year–70 year
Female
Interventional
Not applicable
Barcelona, 08035, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion
Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion
Time frame: 10 min
Effect of abdominal wall activity on abdominal fullness/bloating [measured by 10 cm scale graded from 0 (not at all) to 10 (very much)]
Time frame: 10 min
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)]
Hospital Universitari Vall d'Hebron Research Institute
Other
Factors That Determine the Responses to Meal Ingestion: Effect of Abdominal Wall Activity
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