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Influence of Meal Schedule: Gender Differences

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ClinicalTrials.gov Identifier: NCT03773432
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
Gender differences in the effect of meal schedule will be studied in a parallel design (10 women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as the differences between the responses on both study days. Participants will be instructed to eat standard dinner the day before and to consume standard breakfast at home the day of the afternoon test. Studies will be conducted in a quiet, isolated room with participants siting 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 or disease Intervention/treatment Phase
Healthy Other: Probe meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Factors That Determine the Responses to Meal Ingestion: Meal Schedule and Gender Differences
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : December 4, 2018

Arm Intervention/treatment
Men
In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.
Other: Probe meal
The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).

Women
In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.
Other: Probe meal
The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).




Primary Outcome Measures :
  1. Change in digestive well-being induced by meal schedule [ Time Frame: 1 day ]
    Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to afternoon and morning meals by repeated measures ANCOVA.


Secondary Outcome Measures :
  1. Change in fullness sensation induced by meal schedule [ Time Frame: 1 day ]
    Change in digestive well-being measured by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to afternoon and morning meals by repeated measures ANCOVA.

  2. Change in mood induced by meal schedule [ Time Frame: 1 day ]
    Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to afternoon and morning meals by repeated measures ANCOVA.

  3. Change in hunger/satiety induced by meal schedule [ Time Frame: 1 day ]
    Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to afternoon and morning meals by repeated measures ANCOVA.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773432


Locations
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Spain
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Publications:
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03773432    
Other Study ID Numbers: PR(AG)338/2016G
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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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
meal schedule
postprandial responses
hedonic sensations
homeostatic sensations