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

Appetite 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: NCT03974165
• Other study ID #: 923.20-3-2019
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2019
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite

Intervention

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.
• 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.
• Cereal product
The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
• Reference food
The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.

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 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)