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

NCT ID: NCT03974165

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2019-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appetite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Foods do not differ in shape or color. Participants are blinded to the treatments.

Study Groups

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Cereal-legume product 1

Treatment with cereal-legume product-1

Group Type EXPERIMENTAL

Cereal-legume product 1

Intervention Type 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

Treatment with cereal-legume product-2

Group Type EXPERIMENTAL

Cereal-legume product 2

Intervention Type 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

Treatment with cereal product

Group Type EXPERIMENTAL

Cereal product

Intervention Type 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

Treatment with reference food

Group Type ACTIVE_COMPARATOR

Reference food

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Amalia Yanni

Research and Teaching Associate-Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vaios Karathanos

Role: STUDY_CHAIR

Harokopio University, School of Health Sciences and Education

Alexander Kokkinos

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens, School of Medicine

Amalia Yanni

Role: PRINCIPAL_INVESTIGATOR

Harokopio University, School of Health Sciences and Education

Locations

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

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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923.20-3-2019

Identifier Type: -

Identifier Source: org_study_id

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