Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation

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

Legumes are rich source of proteins and dietary fibers which are associated with satiety and amelioration of postprandial glycemic response. The purpose of the study is to examine the effects of cereal-based products fortified with legumes on appetite regulation and body weight management.

Study Overview

• Status: Completed
• Conditions: Appetite
• Intervention / Treatment: Other: Cereal-legume product 1; Other: Cereal-legume product 2; Other: Cereal product; Other: Reference food

Detailed Description

Postprandial glycemic response as well as response of hormones related to appetite regulation after consumption of cereal-based products fortified with legumes will be evaluated. Apparently healthy subjects with normal body weight and overweight subjects will participate in the study (two protocols). Certain effects on metabolites related to the composition of the different products will be examined. The results of the study will help in the design of a long-term clinical trial regarding the effects of the functional products on body weight management in overweight subjects.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• normal exercise and dietary habits
• weight stable for at least 3 months before enrollment

Exclusion Criteria:

• pregnancy
• diabetes
• chronic medical illness
• use of nutritional supplements
• regular intense exercise
• alcohol consumption >2 drinks per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cereal-legume product 1; Treatment with cereal-legume product-1	Other: Cereal-legume product 1; The intervention examines the effect of cereal based product fortified with legumes-1 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
Experimental: Cereal-legume product 2; Treatment with cereal-legume product-2	Other: Cereal-legume product 2; The intervention examines the effect of cereal based product fortified with legumes-2 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
Experimental: Cereal product; Treatment with cereal product	Other: Cereal product; The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
Active Comparator: Reference food; Treatment with reference food	Other: Reference food; The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose AUC	Change in glucose AUC after consumption of the products compared to the AUC after consumption of the reference food	Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially for each food (totally four times)

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens
• Investigators: Study Chair: Vaios Karathanos, Harokopio University, School of Health Sciences and Education; Principal Investigator: Alexander Kokkinos, National and Kapodistrian University of Athens, School of Medicine; Principal Investigator: Amalia Yanni, Harokopio University, School of Health Sciences and Education

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: June 2, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: appetite regulation; postprandial glucose response; cereal-based products fortified with legumes; postprandial hormone responses
• Other Study ID Numbers: 923.20-3-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No