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Clinical Trials/NCT03084276
NCT03084276CompletedNot Applicable

Factors That Determine the Responses to Meal Ingestion: Meal Composition

Hospital Universitari Vall d'Hebron Research Institute2 sites in 1 country12 target enrollmentStarted: January 16, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
Change in digestive well-being measured after the test meal

Study Overview

Brief Summary

Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy men) 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 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
Crossover
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

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

Outcomes

Primary Outcomes

Change in digestive well-being measured after the test meal

Time Frame: 1 day

Change in average well-being measured by 10 score scales at the end of the test meal.

Secondary Outcomes

  • Change in satiety measured after the test meal(1 day)
  • Change in mood measured after the test meal(1 day)
  • Change in fullness sensation measured after the test meal(1 day)
  • Change in abdominal discomfort/pain sensation measured after the test meal(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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