Diabetes MellitusNCT02589028
The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones
A study testing premeal protein-enriched bar intake and breakfast follows by protein bar in people with Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- premeal protein-enriched bar intake and breakfast follows by protein bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Sep 2016
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5~35 kg/m2
- Healthy volunteer:
- never diagnosed by diabetes and
- fasting plasma glucose <=100mg/dl and HbA1c <6.0%
- participants with diabetes
- diagnosed by diabetes
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- if treated by diet, HbA1c 6.0~9.0%
- if treated by metformin or SU, HbA1c 6.0~10.0%
- if treated by DPP4 inhibitor HbA1c 6.0~9.0%
Who cannot join
- Those who diagnosed by Type 1 diabetes
- History of DKA
- History of insulin therapy
- Allergy to wheat, flour, nuts, milk
- Pregnancy/lactation
- AST or ALT >2.5 times of upper normal reference range
Show all 9Show fewer
- eGFR <30 mL/min/1.73m2
- Hb <10g/dl
- History of GI surgery (except hemorrhoidectomy, appendectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes
The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes.
Read the detailed description
Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.
- Conditions
- Diabetes Mellitus
- Being tested
- premeal protein-enriched bar intake, breakfast follows by protein bar
- Keywords
- diabetes mellitus, incretin hormone, glucose level, GLP-1, GIP, premeal protein
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premeal protein-enriched bar intakeDietary supplement
Also called premeal protein bar
Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.
breakfast follows by protein barOther
Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| premeal protein bar first | Experimental | intervention: premeal protein-enriched bar intake
* protein enriched bar(total serving: 30g, 43.28% carbohydrate; 1.29% fat; 40.39% protein; 42.63% fiber) will be given 30 minutes before breakfast
* protein enriched bar is provided with 150 ml of water
* amount of protein bar : 30g
* breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml Receives: Dietary Supplement: premeal protein-enriched bar intake |
| breakfast first | Other | intervention: breakfast follows by protein bar
* protein enriched bar is provided with 150 ml of water shortly after breakfast
* amount of protein bar : 30g
* breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml Receives: Other: breakfast follows by protein bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucose level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve (AUC) of plasma glucose level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Secondary outcomes (10)
plasma total/active GLP-1 level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma total/active GLP-1 level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma GIP level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma GIP level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma insulin level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma insulin level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma C-peptide level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma C-peptide level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma glucagon level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma glucagon level after breakfast
Measured: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Min Cho, MD, PHD, Study chair, Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589028
- Sponsor's protocol ID
- H-1504-103-666
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2015
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02589028
- Acronym / sponsor ID
- H-1504-103-666
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, incretin hormone, glucose level, GLP-1, GIP, premeal protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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 aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes.
Detailed description
Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premeal protein bar first | Experimental | Dietary Supplement: premeal protein-enriched bar intakeintervention: premeal protein-enriched bar intake * protein enriched bar(total serving: 30g, 43.28% carbohydrate; 1.29% fat; 40.39% protein; 42.63% fiber) will be given 30 minutes before breakfast * protein enriched bar is provided with 150 ml of water * amount of protein bar : 30g * breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml |
| breakfast first | Other | Other: breakfast follows by protein barintervention: breakfast follows by protein bar * protein enriched bar is provided with 150 ml of water shortly after breakfast * amount of protein bar : 30g * breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- BMI 18.5~35 kg/m2
- Healthy volunteer:
- participants with diabetes
Key exclusion criteria (9 listed)
- Those who diagnosed by Type 1 diabetes
- History of DKA
- History of insulin therapy
- Allergy to wheat, flour, nuts, milk
- Pregnancy/lactation
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 |
|---|---|---|
| premeal protein-enriched bar intakeAlso: premeal protein barPremeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water. | Dietary supplement | premeal protein bar first |
| breakfast follows by protein barParticipants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes. | Other | breakfast first |
Primary outcome
plasma glucose level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve (AUC) of plasma glucose level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
10 secondary outcomes
plasma total/active GLP-1 level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma total/active GLP-1 level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma GIP level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma GIP level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma insulin level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma insulin level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma C-peptide level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma C-peptide level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma glucagon level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma glucagon level after breakfast
Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
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 29 Nov 2017.
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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.
Young Min Cho, MD, PHD study chair
Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing premeal protein-enriched bar intake and breakfast follows by protein bar in people with Diabetes Mellitus, run by Seoul National University Hospital at 1 site in South Korea.
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 9 inclusion and 9 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 29 Nov 2017. 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 South Korea. 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?
plasma glucose level after breakfast (time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min). The study lists 2 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 29 Nov 2017.