Cereal-based Products Fortified With Legumes and Effects on Body Weight Management

NCT ID: NCT04176614

Last Updated: 2022-02-14

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-03-25

Brief Summary

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Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

Detailed Description

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Overweight/obese, non-diabetic subjects will participate in the study. Subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily. The effects of dietary intervention on body weight reduction will be examined.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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cereal-legume snack

Certain amount of cereal-legume snack daily for 12 weeks

Group Type EXPERIMENTAL

cereal-legume snack

Intervention Type OTHER

cereal-legume biscuit

cereal snack

Certain amount of cereal snack daily for 12 weeks

Group Type ACTIVE_COMPARATOR

cereal snack

Intervention Type OTHER

cereal biscuit

Interventions

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cereal-legume snack

cereal-legume biscuit

Intervention Type OTHER

cereal snack

cereal biscuit

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

* diabetes
* pregnancy
* chronic medical illness
* use of nutritional supplements
* regular intense exercise
* alcohol consumption \> 2 drinks/day
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amalia Yanni, Dr

Role: PRINCIPAL_INVESTIGATOR

Harokopio University

Alexander Kokkinos, Prof

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

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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62/03072018

Identifier Type: -

Identifier Source: org_study_id

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