Factors That Determine the Response to Meal Ingested: Education
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in digestive well-being measured after a test meal by the end of the intervention versus before.
Study Overview
Brief Summary
The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low temperature and 25 g bread) will be studied in a parallel design. The effects of education will be tested in two different groups in random order: real versus sham education. In each group the responses to a probe meal will be tested on 2 different days before and after the intervention. Participants 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 probe meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- 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
Education
Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the real education group, solutions at suprathreshold concentration for detection will be given with a subsequent comment on the flavor and an explanation of the components and preparation of the soup (low temperature cooking to preserve flavors).
Intervention: Education (Behavioral)
Sham
Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the sham education group solutions at subthreshold concentration for detection with no explanation will be provided.
Intervention: Sham (Behavioral)
Outcomes
Primary Outcomes
Change in digestive well-being measured after a test meal by the end of the intervention versus before.
Time Frame: 1 day
Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention.
Secondary Outcomes
- Change in fullness sensation measured after a test meal by the end of the intervention versus before.(1 day)
- Change in satiety measured after a test meal by the end of the intervention versus before(1 day)
- Change in discomfort/pain measured after a test meal by the end of the intervention versus before(1 day)