Healthy Clinical Trial
Official title:
Factors That Determine the Response to Meal Ingested: Education
Verified date | December 2016 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Fernando Azpiroz | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in digestive well-being measured after a test meal by the end of the intervention versus before. | Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day | |
Secondary | Change in satiety measured after a test meal by the end of the intervention versus before | Change in average satiety measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day | |
Secondary | Change in fullness sensation measured after a test meal by the end of the intervention versus before. | Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day | |
Secondary | Change in discomfort/pain measured after a test meal by the end of the intervention versus before | Change in average fullness measured by 0-10 score scales at the end of the test meal administered before and after intervention. | 1 day |
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