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Completed

NCT Number: NCT03974165

Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation

Legumes are rich source of proteins and dietary fibers which are associated with satiety and amelioration of postprandial glycemic response. The purpose of the study is to examine the effects of cereal-based products fortified with legumes on appetite regulation and body weight management.

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Key information

Conditions

Appetite

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

About this study

Postprandial glycemic response as well as response of hormones related to appetite regulation after consumption of cereal-based products fortified with legumes will be evaluated. Apparently healthy subjects with normal body weight and overweight subjects will participate in the study (two protocols). Certain effects on metabolites related to the composition of the different products will be examined. The results of the study will help in the design of a long-term clinical trial regarding the effects of the functional products on body weight management in overweight subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • normal exercise and dietary habits
  • weight stable for at least 3 months before enrollment

Exclusion criteria

  • pregnancy
  • diabetes
  • chronic medical illness
  • use of nutritional supplements
  • regular intense exercise
  • alcohol consumption >2 drinks per day

Treatment and study plan

Cereal-legume product 1

Other

The intervention examines the effect of cereal based product fortified with legumes-1 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.

Cereal-legume product 2

Other

The intervention examines the effect of cereal based product fortified with legumes-2 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.

Cereal product

Other

The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.

Reference food

Other

The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.

Primary outcomes

  1. Change in glucose AUC

    Time frame: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially for each food (totally four times)

    Change in glucose AUC after consumption of the products compared to the AUC after consumption of the reference food

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2019
Registry last updated
Nov 27, 2019

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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