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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: cereal-legume snack; Other: cereal snack

• Registration Number: NCT04176614
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Study Start: 2020-01-20
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cereal-legume snack	cereal-legume snack	Certain amount of cereal-legume snack daily for 12 weeks
cereal snack	cereal snack	Certain amount of cereal snack daily for 12 weeks

Primary Outcome Measures

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

Trial Locations

Locations (1)

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens; 🇬🇷 Athens, Attiki, Greece