Diet HabitNCT04417504
Metabolic and Prolonged Satiety Effects of a Breakfast Kit
A study testing MobFood breakfast kit in people with Diet Habit, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer the current nutrition market challenges - is formed by a consortium of 47 collaborative entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de Investigação e Inovação) and is financed by… Read more about this study
- Who is it for?
- Ages 23 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- MobFood breakfast kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2020to 31 Oct 2020
- 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 23 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female;
- Born between 1981 and 1996;
- Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2;
- Normoglycemic according to American Diabetes Association criteria [Fasting Plasma Glucose < 100 mg/dl, 2-h plasma glucose value during a 75 g oral glucose tolerance test (OGTT) < 140 mg/dl)];
- Healthy.
Who cannot join
- Overweight or obese (BMI ≥ 25,0 kg/m2);
- Recent body weight loss/gain >10%, within previous 3 months;
- Being on a weight loss/other special diet (e.g. Paleo diet, Atkins diet, flexitarian diet or ketogenic diet), within previous 3 months;
- Clinically significant illness, including:
- type 1 or type 2 diabetes; liver disease e.g. cirrhosis; malignancy; pancreatitis or other malabsorption; gastrointestinal disorders e. g. intestinal bowel disorder, celiac disease; previous weight loss surgery e.g. bariatric surgery; chronic respiratory, neurological, psychiatric, musculoskeletal diseases/conditions; diagnosed eating disorders.
- Individuals who don't regularly consume breakfast;
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- Having taken antibiotics within the 12 weeks prior to beginning the study;
- Taking other medication that could potentially affect body weight, glucose metabolism and/or appetite (e.g. GLP-1 analogues);
- Being engaged in competitive sports;
- Having >14 or >8 (males and females, respectively) alcoholic units/week; misuse of drugs;
- Having donated blood within one month prior to the beginning of the study;
- Nut or milk allergy, or other food allergy or intolerance that would compromise compliance with the study protocol;
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
NOVA Medical School, NOVA University of Lisbon
Lisbon
Conceição Calhau, PhD, +351918482491, mobfood@nms.unl.pt
About this study
Official title: Metabolic and Prolonged Satiety Effects of a Breakfast Kit: a Randomized Controlled Trial
The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer the current nutrition market challenges - is formed by a consortium of 47 collaborative entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de Investigação e Inovação) and is financed by Structural European Funds of Investment.
The project is currently investigating and undertaking collaborative scientific and technological strategies based on R\&D and innovation, in order to boost and promote a more competitive national food industry, capable of overcoming the current challenges, including those of the Millennial Generation. This group is particularly conscious of the impact of food behaviour and food choices on health but extremely vulnerable to dietary imbalance. Strategies to improve Millenials' nutrition while providing conscious food products are needed.
This study is a randomised, cross-over controlled trial designed to test the metabolic effect, particularly in terms of appetite control and glycaemic response of a breakfast kit (nutritionally balanced and innovative), recently developed as part of the collaborative project MobFood_PPS4.
- Conditions
- Diet Habit
- Being tested
- MobFood breakfast kit, Control isocaloric breakfast
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobFood breakfast kitOther
Cereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood_PPS4.
Control isocaloric breakfastOther
White bread, butter and milk.
| Study group | Role | What they receive |
|---|---|---|
| MobFood breakfast kit | Experimental | Not described Receives: Other: MobFood breakfast kit |
| Control isocaloric breakfast | Experimental | Not described Receives: Other: Control isocaloric breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms
The iAUC for glucose will be calculated based on the concentration curve following consumption of the test and control products, over 2h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC (pmol/l*min) for glucagon-like peptide-1 (GLP-1) between the 2 arms
The iAUC for GLP-1 will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC (pmol/l*min) for peptide YY (PYY) between the 2 arms
The iAUC for PYY will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC (pmol/l*min) for cholecystokinin (CKK) between the 2 arms
The iAUC for CKK will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC (pmol/l*min) for ghrelin between the 2 arms
The iAUC for ghrelin will be calculated based on the concentration curve following consumption of test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC (pmol/l*min) for glucagon between the 2 arms
The iAUC for glucagon will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Secondary outcomes (3)
Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms
The iAUC for TG will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms
The iAUC for NEFA will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in subjective feelings of hunger/satiety between the 2 arms
Difference in subjective feelings of hunger/satiety from fasting state to post-prandial state with the consumption of the test and control products
Measured: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Technology and Services Research, NOVA Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417504
- Sponsor's protocol ID
- MobFood
- Status last verified
- Nov 2019
- First submitted
- 1 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Prolonged Satiety Effects of a Breakfast Kit: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04417504
- Acronym / sponsor ID
- MobFood
- Conditions
- Diet Habit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Center for Health Technology and Services Research, NOVA Medical School
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 4 Jun 2020 (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.
The mobilizing programme MobFood - mobilizing scientific knoweledge and technology to answer the current nutrition market challenges - is formed by a consortium of 47 collaborative entities, between the industry and ENESIIs (Entidades Não Empresariais do Sistema de Investigação e Inovação) and is financed by Structural European Funds of Investment.
The project is currently investigating and undertaking collaborative scientific and technological strategies based on R\&D and innovation, in order to boost and promote a more competitive national food industry, capable of overcoming the current challenges, including those of the Millennial Generation. This group is particularly conscious of the impact of food behaviour and food choices on health but extremely vulnerable to dietary imbalance. Strategies to improve Millenials' nutrition while providing conscious food products are needed.
This study is a randomised, cross-over controlled trial designed to test the metabolic effect, particularly in terms of appetite control and glycaemic response of a breakfast kit (nutritionally balanced and innovative), recently developed as part of the collaborative project MobFood_PPS4.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MobFood breakfast kit | Experimental | Other: MobFood breakfast kit |
| Control isocaloric breakfast | Experimental | Other: Control isocaloric breakfast |
Who may qualify
- Ages
- 23 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female;
- Born between 1981 and 1996;
- Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2;
- Normoglycemic according to American Diabetes Association criteria [Fasting Plasma Glucose < 100 mg/dl, 2-h plasma glucose value during a 75 g oral glucose tolerance test (OGTT) < 140 mg/dl)];
- Healthy.
Key exclusion criteria (13 listed)
- Overweight or obese (BMI ≥ 25,0 kg/m2);
- Recent body weight loss/gain >10%, within previous 3 months;
- Being on a weight loss/other special diet (e.g. Paleo diet, Atkins diet, flexitarian diet or ketogenic diet), within previous 3 months;
- Clinically significant illness, including:
- type 1 or type 2 diabetes; liver disease e.g. cirrhosis; malignancy; pancreatitis or other malabsorption; gastrointestinal disorders e. g. intestinal bowel disorder, celiac disease; previous weight loss surgery e.g. bariatric surgery; chronic respiratory, neurological, psychiatric, musculoskeletal diseases/conditions; diagnosed eating disorders.
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 |
|---|---|---|
| MobFood breakfast kitCereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood_PPS4. | Other | MobFood breakfast kit |
| Control isocaloric breakfastWhite bread, butter and milk. | Other | Control isocaloric breakfast |
Primary outcome
Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
The iAUC for glucose will be calculated based on the concentration curve following consumption of the test and control products, over 2h
Differences in the iAUC (pmol/l*min) for glucagon-like peptide-1 (GLP-1) between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
The iAUC for GLP-1 will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Differences in the iAUC (pmol/l*min) for peptide YY (PYY) between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
The iAUC for PYY will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Differences in the iAUC (pmol/l*min) for cholecystokinin (CKK) between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
The iAUC for CKK will be calculated based on the concentration curve following consumption of the test and control products, over 3h
Differences in the iAUC (pmol/l*min) for ghrelin between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
The iAUC for ghrelin will be calculated based on the concentration curve following consumption of test and control products, over 3h
Differences in the iAUC (pmol/l*min) for glucagon between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
The iAUC for glucagon will be calculated based on the concentration curve following consumption of the test and control products, over 3h
3 secondary outcomes
Differences in the iAUC (mg/dl*min) for triacylglycerides (TG) between 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in the iAUC for (mmol/l*min) non-esterified fatty acids (NEFA) between 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Differences in subjective feelings of hunger/satiety between the 2 arms
Time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobFood breakfast kit in people with Diet Habit, run by Universidade do Porto at 1 site in Portugal.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conceição Calhau, PhD (00351 218803035 ext. 20401, ccalhau@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the incremental area under the curve (iAUC, mg/dl*min) for glucose response between the 2 arms (time frame: at CID1 (1 week after screening) and CID2 (at least 2 days after visit 1)). The study lists 6 primary outcomes in all. 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 9 Jun 2020.