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

Not Applicable

Completed

• Conditions: Appetite
• Interventions: Other: Cereal product; Other: Cereal-legume product 2; Other: Cereal-legume product 1; Other: Reference food

• Registration Number: NCT03974165
• Lead Sponsor: Harokopio University

Brief Summary

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.

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 Timeline

• Study Start: 2019-05-07
• Status Verified: 2019-06
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-02
• Study First Posted: 2019-06-04
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cereal product	Cereal product	Treatment with cereal product
Cereal-legume product 2	Cereal-legume product 2	Treatment with cereal-legume product-2
Cereal-legume product 1	Cereal-legume product 1	Treatment with cereal-legume product-1
Reference food	Reference food	Treatment with reference food

Primary Outcome Measures

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

Trial Locations

Locations (1)

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