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

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

cereal-legume snack

cereal snack

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring cereal-based snack fortified with legumes, body weight reduction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cereal-legume snack

cereal snack

Arm Description

Certain amount of cereal-legume snack daily for 12 weeks

Certain amount of cereal snack daily for 12 weeks

Outcomes

Primary Outcome Measures

Change in body weight

Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack

Secondary Outcome Measures

Full Information

NCT ID

NCT04176614

First Posted

November 22, 2019

Last Updated

February 11, 2022

Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT04176614

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 20, 2020 (Actual)

Primary Completion Date

March 25, 2021 (Actual)

Study Completion Date

March 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

cereal-based snack fortified with legumes, body weight reduction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cereal-legume snack

Arm Type

Experimental

Arm Description

Certain amount of cereal-legume snack daily for 12 weeks

Arm Title

cereal snack

Arm Type

Active Comparator

Arm Description

Certain amount of cereal snack daily for 12 weeks

Intervention Type

Other

Intervention Name(s)

cereal-legume snack

Intervention Description

cereal-legume biscuit

Intervention Type

Other

Intervention Name(s)

cereal snack

Intervention Description

cereal biscuit

Primary Outcome Measure Information:

Title

Change in body weight

Description

Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amalia Yanni, Dr

Organizational Affiliation

Harokopio University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexander Kokkinos, Prof

Organizational Affiliation

National and Kapodistrian University of Athens

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Athens

State/Province

Attiki

ZIP/Postal Code

11527

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

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

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