- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04176614
Cereal-based Products Fortified With Legumes and Effects on Body Weight Management
February 11, 2022 updated by: Amalia Yanni, Harokopio University
Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management
Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management.
The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Overweight/obese, non-diabetic subjects will participate in the study.
Subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily.
The effects of dietary intervention on body weight reduction will be examined.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Attiki
-
Athens, Attiki, Greece, 11527
- Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- normal exercise and dietary habits
- weight stable for at least 3 months before enrollment
Exclusion Criteria:
- diabetes
- pregnancy
- chronic medical illness
- use of nutritional supplements
- regular intense exercise
- alcohol consumption > 2 drinks/day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: cereal-legume snack
Certain amount of cereal-legume snack daily for 12 weeks
|
cereal-legume biscuit
|
ACTIVE_COMPARATOR: cereal snack
Certain amount of cereal snack daily for 12 weeks
|
cereal biscuit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight
Time Frame: 12 weeks
|
Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amalia Yanni, Dr, Harokopio University
- Principal Investigator: Alexander Kokkinos, Prof, National and Kapodistrian University of Athens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 20, 2020
Primary Completion (ACTUAL)
March 25, 2021
Study Completion (ACTUAL)
March 25, 2021
Study Registration Dates
First Submitted
November 22, 2019
First Submitted That Met QC Criteria
November 22, 2019
First Posted (ACTUAL)
November 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 14, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62/03072018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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