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

• Sponsor: Harokopio University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04176614
• Collaborator: National and Kapodistrian University of Athens (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Other: cereal-legume snack; Other: cereal snack	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management
• Actual Study Start Date: Jan 20, 2020
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Mar 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cereal-legume snack Certain amount of cereal-legume snack daily for 12 weeks	Other: cereal-legume snack; cereal-legume biscuit
Active Comparator: cereal snack Certain amount of cereal snack daily for 12 weeks	Other: cereal snack; cereal biscuit

Outcome Measures

Primary Outcome Measures

1. Change in body weight [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens	Athens	Attiki	Greece	11527

Sponsors and Collaborators

• Harokopio University
• National and Kapodistrian University of Athens

Investigators

• Principal Investigator: Amalia Yanni, Dr, Harokopio University
• Principal Investigator: Alexander Kokkinos, Prof, National and Kapodistrian University of Athens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amalia Yanni, Research and Teaching Associate-Staff, Principal Investigator, Harokopio University
• ClinicalTrials.gov Identifier: NCT04176614
• Other Study ID Numbers: 62/03072018
• First Posted: Nov 25, 2019
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amalia Yanni, Research and Teaching Associate-Staff, Principal Investigator, Harokopio University: cereal-based snack fortified with legumes; body weight reduction
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Feb 14, 2022