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Clinical Trials/NCT03974165
NCT03974165
Completed
Not Applicable

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

Harokopio University1 site in 1 country15 target enrollmentStarted: May 7, 2019Last updated:
ConditionsAppetite

Overview

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Change in glucose AUC

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

Foods do not differ in shape or color. Participants are blinded to the treatments.

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in glucose AUC

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amalia Yanni

Research and Teaching Associate-Staff

Harokopio University

Study Sites (1)

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