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OpenTrials
Completed

NCT Number: NCT02615613

The Effect of Food Hedonics on Appetite Hormones Levels

30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. Accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). Two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. The two versions will differ only in palatability and will be equicaloric. Subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. Each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. The quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gender: Male
  • Age: 18-50 years
  • Body Mass Index (BMI): 18.5-24.9 kg/m2
  • Stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status)

Exclusion criteria

  • Smoking
  • Substance abuse such as alcohol or drugs
  • Medical or psychological illness
  • Use of medications
  • Previous gastrointestinal surgery
  • History of weight fluctuation (weight loss of greater than 5% within the past 3 months)

Treatment and study plan

Low Acceptability Meal

Other

High acceptability meal

Other

Primary outcomes

  1. Food acceptability score

    Time frame: Two weeks

  2. Ghrelin level

    Time frame: Two weeks

Secondary outcomes

  1. Glucose level

    Time frame: Two weeks

  2. Appetite score on the visual analogue scale

    Time frame: Two weeks

  3. Insulin level

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight Male Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2015
Registry last updated
Nov 30, 2015

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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