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Completed

NCT Number: NCT03084276

Effect of Meal Composition on the Responses to Meal Ingestion

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

Male

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

High-fat Meal

Other

High-fat meal

Low-fat meal

Other

Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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.

Other outcomes

  1. Meal palatability

    Time frame: 1 day

    Meal palatability measured by 10 score scales at the end of the test 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: Meal Composition

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Apr 25, 2017

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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