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

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ClinicalTrials.gov Identifier: NCT03974165
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Amalia Yanni, Harokopio University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Appetite Other: Cereal-legume product 1 Other: Cereal-legume product 2 Other: Cereal product Other: Reference food Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
  1. Healthy subjects with normal body weight receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
  2. Overweight subjects receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
Masking: Single (Participant)
Masking Description: Foods do not differ in shape or color. Participants are blinded to the treatments.
Primary Purpose: Prevention
Official Title: Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Cereal-legume product 1
Treatment with cereal-legume product-1
Other: Cereal-legume product 1
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.

Experimental: Cereal-legume product 2
Treatment with cereal-legume product-2
Other: Cereal-legume product 2
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.

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

Active Comparator: Reference food
Treatment with reference food
Other: Reference food
The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974165


Contacts
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Contact: Alexander Kokkinos +302107462683 akokkinos@med.uoa.gr
Contact: Amalia Yanni +302109549174 ayanni@hua.gr

Locations
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Greece
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens Recruiting
Athens, Attiki, Greece, 11527
Contact: Alexander Kokkinos    +302107462683    akokkinos@med.uoa.gr   
Contact: Nikolaos Tentolouris    +302107462683    ntentol@med.uoa.gr   
Sponsors and Collaborators
Harokopio University
National and Kapodistrian University of Athens
Investigators
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Study Chair: Vaios Karathanos Harokopio University, School of Health Sciences and Education
Principal Investigator: Alexander Kokkinos National and Kapodistrian University of Athens, School of Medicine
Principal Investigator: Amalia Yanni Harokopio University, School of Health Sciences and Education

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Responsible Party: Amalia Yanni, Research and Teaching Associate-Staff, Harokopio University
ClinicalTrials.gov Identifier: NCT03974165     History of Changes
Other Study ID Numbers: 923.20-3-2019
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amalia Yanni, Harokopio University:
cereal-based products fortified with legumes
appetite regulation
postprandial glucose response
postprandial hormone responses