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Trial record 2 of 243111 for:    ALL

Palatability and Postprandial Sensations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT03134365
First received: April 25, 2017
Last updated: NA
Last verified: April 2017
History: No changes posted
  Purpose

Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days.

Participants (22 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 5 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.


Condition Intervention
Healthy
Other: Mixed meal
Other: Combined meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Outcomes Assessor
Primary Purpose: Other
Official Title: Factors to Determine the Responses to Meal Ingestion: Palatability

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Meal palatability [ Time Frame: 1 day ]
    Meal palatability measured by 10 score scales at the end of the test meal

  • 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 Outcome Measures:
  • Change in satiety measured after the test meal [ Time Frame: 1 day ]
    Change in average satiety measured by 10 score scales at the end of the test meal

  • Change in fullness sensation measured after the test meal [ Time Frame: 1 day ]
    Change in average fullness measured by 10 score scales at the end of the test meal

  • Change in abdominal discomfort/pain sensation measured after the test meal [ Time Frame: 1 day ]
    Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal

  • Change in mood measured after the test meal [ Time Frame: 1 day ]
    Change in average mood measured by 10 score scales at the end of the test meal.


Enrollment: 22
Actual Study Start Date: August 4, 2016
Study Completion Date: December 2, 2016
Primary Completion Date: November 23, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mixed meal Other: Mixed meal
Mixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability.
Active Comparator: Combined meal Other: Combined meal
Combined meal.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03134365

Locations
Spain
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
  More Information

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03134365     History of Changes
Other Study ID Numbers: PR(AG)338/2016C
Study First Received: April 25, 2017
Last Updated: April 25, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
meal ingestion
palatability
postprandial responses
hedonic response

ClinicalTrials.gov processed this record on April 28, 2017