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

NCT03974165 | Completed DMC

• 1 other identifier: 923.20-3-2019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite

Keywords

cereal-based products fortified with legumes; appetite regulation; postprandial glucose response; postprandial hormone responses

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

Cereal-legume product 1

EXPERIMENTAL

Treatment with cereal-legume product-1

Other: Cereal-legume product 1

Cereal-legume product 2

EXPERIMENTAL

Treatment with cereal-legume product-2

Other: Cereal-legume product 2

Cereal product

EXPERIMENTAL

Treatment with cereal product

Other: Cereal product

Reference food

ACTIVE COMPARATOR

Treatment with reference food

Other: Reference food

Interventions

Cereal-legume product 1 OTHER

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 1

Cereal-legume product 2 OTHER

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-legume product 2

Cereal product OTHER

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

Cereal product

Reference food OTHER

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

Reference food

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

Location

Study Officials

• Vaios Karathanos

  Harokopio University, School of Health Sciences and Education

  STUDY CHAIR

• Alexander Kokkinos

  National and Kapodistrian University of Athens, School of Medicine

  PRINCIPAL INVESTIGATOR

• Amalia Yanni

  Harokopio University, School of Health Sciences and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Foods do not differ in shape or color. Participants are blinded to the treatments.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Teaching Associate-Staff

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: May 7, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)