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Completed

NCT Number: NCT03408977

Meal Enjoyment and Tolerance: Sex Differences

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probe meal

Other

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.

Primary outcomes

  1. Meal tolerance

    Time frame: 100 min

    Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale).

Secondary outcomes

  1. Change in digestive well-being induced by the probe meal

    Time frame: 1 day

    Change in well-being measured by 10 score scales during and after the probe meal.

  2. Change in fullness sensation induced by the probe meal

    Time frame: 1 day

    Change in fullness sensation measured by 10 score scales during and after the probe meal.

  3. Change in mood induced by the probe meal

    Time frame: 1 day

    Change in mood measured by 10 score scales during and after the probe meal.

  4. Change in abdominal discomfort induced by the probe meal

    Time frame: 1 day

    Change in abdominal discomfort measured by 10 score scales during and after the probe meal.

  5. Change in hunger/satiety induced by the probe meal

    Time frame: 1 day

    Change in hunger/satiety measured by 10 score scales during and after the probe meal.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Factors That Determine the Responses to Meal Ingestion: Sex Differences

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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