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CompletedNCT03974165Updated Nov 27, 2019

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

An interventional study of Cereal-legume product 1 and Cereal-legume product 2 in Appetite, sponsored by Harokopio University. Completed at 1 site in Greece. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Harokopio University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Appetite

Keywords

  • cereal-based products fortified with legumes
  • appetite regulation
  • postprandial glucose response
  • postprandial hormone responses
03

In context

Lead sponsor

Harokopio University is the lead sponsor of 65 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • diabetes
  • chronic medical illness
  • use of nutritional supplements
  • regular intense exercise
  • alcohol consumption >2 drinks per day
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Cereal-legume product 1

    Treatment with cereal-legume product-1

    Other: Cereal-legume product 1

  • Experimental
    Cereal-legume product 2

    Treatment with cereal-legume product-2

    Other: Cereal-legume product 2

  • Experimental
    Cereal product

    Treatment with cereal product

    Other: Cereal product

  • Active comparator
    Reference food

    Treatment with reference food

    Other: Reference food

Interventions

  • OtherCereal-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.

  • OtherCereal-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.

  • OtherCereal product

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

  • OtherReference food

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

06

What researchers measure

Primary outcomes

  1. Change in glucose AUC

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

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

07

Study locations

1 site
  • Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
    Athens, Attiki 11527, Greece
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03974165
Lead sponsor
Harokopio University
Collaborators
National and Kapodistrian University of Athens
Responsible party
Amalia Yanni (Research and Teaching Associate-Staff, Harokopio University) — Principal investigator
First posted
Jun 4, 2019
Start date
May 7, 2019
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019
Last update
Nov 27, 2019

Study contacts

Vaios Karathanos
study chair · Harokopio University, School of Health Sciences and Education
Alexander Kokkinos
principal investigator · National and Kapodistrian University of Athens, School of Medicine
Amalia Yanni
principal investigator · Harokopio University, School of Health Sciences and Education

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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