Clinical trial NCT03974165: Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation
Official title: Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Keywords: cereal-based products fortified with legumes
appetite regulation
postprandial glucose response
postprandial hormone responses
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2019-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1. Healthy subjects with normal body weight receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
2. Overweight subjects receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glucose AUC
timeFrame: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially for each food (totally four times)
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
state: Attiki
Study officials:
affiliation: Harokopio University, School of Health Sciences and Education
name: Vaios Karathanos
role: STUDY_CHAIR
affiliation: National and Kapodistrian University of Athens, School of Medicine
name: Alexander Kokkinos
role: PRINCIPAL_INVESTIGATOR
affiliation: Harokopio University, School of Health Sciences and Education
name: Amalia Yanni
role: PRINCIPAL_INVESTIGATOR
References: