Meal Enjoyment and Tolerance: Sex Differences
Factors That Determine the Responses to Meal Ingestion: Sex Differences
1 other identifier
interventional
20
1 country
1
Brief Summary
Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) 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 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2017
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2018
CompletedFirst Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedFebruary 26, 2018
January 1, 2018
4 months
January 18, 2018
February 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Meal tolerance
Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale).
100 min
Secondary Outcomes (5)
Change in digestive well-being induced by the probe meal
1 day
Change in fullness sensation induced by the probe meal
1 day
Change in mood induced by the probe meal
1 day
Change in abdominal discomfort induced by the probe meal
1 day
Change in hunger/satiety induced by the probe meal
1 day
Study Arms (2)
Men
EXPERIMENTALWomen
EXPERIMENTALInterventions
The probe meal will be served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.
Eligibility Criteria
You may qualify if:
- non-obese
You may not qualify if:
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Vall d'Hebron
Barcelona, 08035, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
January 24, 2018
Study Start
September 1, 2017
Primary Completion
December 20, 2017
Study Completion
January 8, 2018
Last Updated
February 26, 2018
Record last verified: 2018-01