Cereal-based Products Fortified With Legumes and Effects... | NCT04176614

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

NCT04176614

Sponsor

Harokopio University

Status

Completed

Last Update Posted

Feb 14, 2022Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Overweight and Obesity

Interventions

cereal-legume snack
cereal snack

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Actual

Primary Completion Date

Mar 25, 2021Actual

Completion Date

Mar 25, 2021Actual

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 22, 2019

First Posted Date

Nov 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2022

Last Update Posted Date

Feb 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amalia Yanni, Research and Teaching Associate-Staff, Principal Investigator, Harokopio UniversityPrincipal Investigator

Lead Sponsor

Harokopio UniversityOTHER

Collaborators

Name	Class
National and Kapodistrian University of Athens	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cereal-legume snack	Experimental	Certain amount of cereal-legume snack daily for 12 weeks	Other: cereal-legume snack
cereal snack	Active Comparator	Certain amount of cereal snack daily for 12 weeks	Other: cereal snack

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cereal-legume snack	Other	cereal-legume biscuit	cereal-legume snack

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in body weight	Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amalia Yanni, Dr	Harokopio University	Principal Investigator
Alexander Kokkinos, Prof	National and Kapodistrian University of Athens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens		Athens	Attica	11527	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.