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NCT04176614 Clinical Trial

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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04176614
Other study ID # 62/03072018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2020
Est. completion date March 25, 2021

Study information
Verified date February 2022
Source Harokopio University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date March 25, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• cereal-legume snack
cereal-legume biscuit
• cereal snack
cereal biscuit

Locations
Country Name City State
Greece Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens Athens Attiki

Sponsors (2)
Lead Sponsor Collaborator
Harokopio University National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in body weight Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack 12 weeks
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