Overweight and ObesityNCT04176614
Cereal-based Products Fortified With Legumes and Effects on Body Weight Management
A study testing cereal-legume snack and cereal snack in people with Overweight and Obesity, run by Harokopio University at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- cereal-legume snack and cereal snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jan 2020to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal exercise and dietary habits
- weight stable for at least 3 months before enrollment
Who cannot join
- diabetes
- pregnancy
- chronic medical illness
- use of nutritional supplements
- regular intense exercise
- alcohol consumption > 2 drinks/day
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
Athens, Attica, 11527
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- cereal-legume snack, cereal snack
- Keywords
- cereal-based snack fortified with legumes, body weight reduction
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cereal-legume snackOther
cereal-legume biscuit
cereal snackOther
cereal biscuit
| Study group | Role | What they receive |
|---|---|---|
| cereal-legume snack | Experimental | Certain amount of cereal-legume snack daily for 12 weeks Receives: Other: cereal-legume snack |
| cereal snack | Active comparator | Certain amount of cereal snack daily for 12 weeks Receives: Other: cereal snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 Jan 2020
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Amalia Yanni, Harokopio University
- Investigators
- Amalia Yanni, Dr, Principal investigator, Harokopio UniversityAlexander Kokkinos, Prof, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176614
- Sponsor's protocol ID
- 62/03072018
- Status last verified
- Feb 2022
- First submitted
- 22 Nov 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management
- ClinicalTrials.gov ID
- NCT04176614
- Acronym / sponsor ID
- 62/03072018
- Conditions
- Overweight and Obesity
- Keywords
- cereal-based snack fortified with legumes, body weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| cereal-legume snack | Experimental | Other: cereal-legume snackCertain amount of cereal-legume snack daily for 12 weeks |
| cereal snack | Active comparator | Other: cereal snackCertain amount of cereal snack daily for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal exercise and dietary habits
- weight stable for at least 3 months before enrollment
Key exclusion criteria (6 listed)
- diabetes
- pregnancy
- chronic medical illness
- use of nutritional supplements
- regular intense exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cereal-legume snackcereal-legume biscuit | Other | cereal-legume snack |
| cereal snackcereal biscuit | Other | cereal snack |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amalia Yanni, Dr principal investigator
Harokopio University
Alexander Kokkinos, Prof principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cereal-legume snack and cereal snack in people with Overweight and Obesity, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.