AppetiteNCT03974165
Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation
A study testing Cereal-legume product 1, Cereal-legume product 2 and Cereal product in people with Appetite, run by Harokopio University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Cereal-legume product 1, Cereal-legume product 2 and Cereal product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 7 May 2019to 30 Aug 2019
- 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 20 to 40 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
- pregnancy
- diabetes
- chronic medical illness
- use of nutritional supplements
- regular intense exercise
- alcohol consumption >2 drinks per 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 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.
Read the 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.
- Conditions
- Appetite
- Being tested
- Cereal-legume product 1, Cereal-legume product 2, Cereal product, Reference food
- Keywords
- cereal-based products fortified with legumes, appetite regulation, postprandial glucose response, postprandial hormone responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal-legume product 1Other
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 2Other
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 productOther
The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
Reference foodOther
The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
| Study group | Role | What they receive |
|---|---|---|
| Cereal-legume product 1 | Experimental | Treatment with cereal-legume product-1 Receives: Other: Cereal-legume product 1 |
| Cereal-legume product 2 | Experimental | Treatment with cereal-legume product-2 Receives: Other: Cereal-legume product 2 |
| Cereal product | Experimental | Treatment with cereal product Receives: Other: Cereal product |
| Reference food | Active comparator | Treatment with reference food Receives: Other: Reference food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose AUC
Change in glucose AUC after consumption of the products compared to the AUC after consumption of the reference food
Measured: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially for each food (totally four times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start7 May 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 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
- Vaios Karathanos, Study chair, Harokopio University, School of Health Sciences and EducationAlexander Kokkinos, Principal investigator, National and Kapodistrian University of Athens, School of MedicineAmalia Yanni, Principal investigator, Harokopio University, School of Health Sciences and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974165
- Sponsor's protocol ID
- 923.20-3-2019
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 27 Nov 2019
- 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 27 Nov 2019. 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
- NCT03974165
- Acronym / sponsor ID
- 923.20-3-2019
- Conditions
- Appetite
- Keywords
- cereal-based products fortified with legumes, appetite regulation, postprandial glucose response, postprandial hormone responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 7 May 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 4 Jun 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 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cereal-legume product 1 | Experimental | Other: Cereal-legume product 1Treatment with cereal-legume product-1 |
| Cereal-legume product 2 | Experimental | Other: Cereal-legume product 2Treatment with cereal-legume product-2 |
| Cereal product | Experimental | Other: Cereal productTreatment with cereal product |
| Reference food | Active comparator | Other: Reference foodTreatment with reference food |
Who may qualify
- Ages
- 20 to 40 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)
- pregnancy
- diabetes
- 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 product 1The 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. | Other | Cereal-legume product 1 |
| Cereal-legume product 2The 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. | Other | Cereal-legume product 2 |
| Cereal productThe intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects. | Other | Cereal product |
| Reference foodThe intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects. | Other | Reference food |
Primary outcome
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
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 27 Nov 2019.
- 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.
Vaios Karathanos study chair
Harokopio University, School of Health Sciences and Education
Alexander Kokkinos principal investigator
National and Kapodistrian University of Athens, School of Medicine
Amalia Yanni principal investigator
Harokopio University, School of Health Sciences and Education
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 product 1, Cereal-legume product 2 and Cereal product in people with Appetite, 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 27 Nov 2019. 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 glucose AUC (time frame: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially for each food (totally four times)). 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 27 Nov 2019.