Factors That Determine the Responses to Meal Ingestion: Effect of Abdominal Wall Activity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Changes in abdominal fullness/bloating sensation induced by the probe meal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Diaphragmatic contraction
Intervention: Diaphragmatic contraction (Behavioral)
Diaphragmatic relaxation
Intervention: Diaphagmatic relaxation (Behavioral)
Outcomes
Primary Outcomes
Changes in abdominal fullness/bloating sensation induced by the probe meal
Time Frame: 10 min
Effect of abdominal wall activity on abdominal fullness/bloating \[measured by 10 cm scale graded from 0 (not at all) to 10 (very much)\]
Secondary Outcomes
- Changes in digestive well-being sensation induced by the probe meal(10 min)