Diabetes MellitusNCT01997281
The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
A study testing dietary fiber-enriched cereal and conventional cereal 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 assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- dietary fiber-enriched cereal and conventional cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- HbA1c 6.5~8.5%
- on life style modification or metformin monotherapy at the time of screening
Who cannot join
- on sulfonylurea or insulin therapy at the time of screening
- allergy to wheat, flour, other cereals or nuts
- lactose intolerance
- pregnancy / lactation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.
Read the detailed description
Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.
- Conditions
- Diabetes Mellitus
- Being tested
- dietary fiber-enriched cereal, conventional cereal
- Keywords
- dietary fiber, diabetes mellitus, gut hormone
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiber-enriched cerealDietary supplement
- provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
- amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.)
- one serving of steamed egg is added for dinner and breakfast
conventional cerealOther
- provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
- amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.)
- one serving (40g) of steamed egg is added for dinner and breakfast
| Study group | Role | What they receive |
|---|---|---|
| DF-cereal | Experimental | * dietary fiber-enriched cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
* amount of cereal: 79 g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.)
* one serving (40g) of steamed egg is added for dinner and breakfast Receives: Dietary Supplement: dietary fiber-enriched cereal |
| conventional cereal | Other | * conventional cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
* amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.)
* one serving (40g) of steamed egg is added for dinner and breakfast Receives: Other: conventional cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal
To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels.
Measured: every 30 minutes from 8 a.m. to noon on the second day
Secondary outcomes (11)
AUC of Plasma Total GIP Levels After Intake of the Study Meal
Measured: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucose Levels After Intake of the Study Meal
Measured: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Insulin Levels After Intake of the Study Meal
Measured: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucagon Levels After Intake of the Study Meal
Measured: every 30 minutes from 8 a.m. to noon on the second day
AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal
Measured: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Total GIP Levels After Lunch
Measured: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucose Levels After Lunch
Measured: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Insulin Levels After Lunch
Measured: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucagon Levels After Lunch
Measured: every 30 minutes from noon to 4 p.m. on the second day
AUC of Serum Free Fatty Acid Levels After Lunch
Measured: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Total GLP-1 Levels After Lunch
Measured: every 30 minutes from noon to 4 p.m. on the second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 28 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, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997281
- Sponsor's protocol ID
- H-1307-133-508
- Other IDs
- 0620132990
- Status last verified
- Aug 2014
- First submitted
- 22 Nov 2013
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kim EK, Oh TJ, Kim LK, Cho YM. Improving Effect of the Acute Administration of Dietary Fiber-Enriched Cereals on Blood Glucose Levels and Gut Hormone Secretion. J Korean Med Sci. 2016 Feb;31(2):222-30. doi: 10.3346/jkms.2016.31.2.222. Epub 2016 Jan 26.
PubMed 26839476
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones
- ClinicalTrials.gov ID
- NCT01997281
- Acronym / sponsor ID
- H-1307-133-508
- Conditions
- Diabetes Mellitus
- Keywords
- dietary fiber, diabetes mellitus, gut hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 16 Nov 2020
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 assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.
Detailed description
Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DF-cereal | Experimental | Dietary Supplement: dietary fiber-enriched cereal* dietary fiber-enriched cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) * amount of cereal: 79 g (285.7 kcal) for dinner and breakfast, 38.5g (142.9 kcal) for night snack (10 p.m.) * one serving (40g) of steamed egg is added for dinner and breakfast |
| conventional cereal | Other | Other: conventional cereal* conventional cereal is provided with milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) * amount of cereal: 80g (285.7 kcal) for dinner and breakfast, 40g (142.9 kcal) for night snack (10 p.m.) * one serving (40g) of steamed egg is added for dinner and breakfast |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes mellitus
- HbA1c 6.5~8.5%
- on life style modification or metformin monotherapy at the time of screening
Key exclusion criteria (4 listed)
- on sulfonylurea or insulin therapy at the time of screening
- allergy to wheat, flour, other cereals or nuts
- lactose intolerance
- 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 |
|---|---|---|
| dietary fiber-enriched cereal* provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) * amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.) * one serving of steamed egg is added for dinner and breakfast | Dietary supplement | DF-cereal |
| conventional cereal* provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.) * amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.) * one serving (40g) of steamed egg is added for dinner and breakfast | Other | conventional cereal |
Primary outcome
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal
Time frame: every 30 minutes from 8 a.m. to noon on the second day
To see the changes in the secretion of GLP-1 with dietary fiber enriched cereal, we will calculate the AUC of the plasma total GLP-1 levels.
11 secondary outcomes
AUC of Plasma Total GIP Levels After Intake of the Study Meal
Time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucose Levels After Intake of the Study Meal
Time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Insulin Levels After Intake of the Study Meal
Time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Glucagon Levels After Intake of the Study Meal
Time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of Serum Free Fatty Acid Levels After Intake of the Study Meal
Time frame: every 30 minutes from 8 a.m. to noon on the second day
AUC of Plasma Total GIP Levels After Lunch
Time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucose Levels After Lunch
Time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Insulin Levels After Lunch
Time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Glucagon Levels After Lunch
Time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of Serum Free Fatty Acid Levels After Lunch
Time frame: every 30 minutes from noon to 4 p.m. on the second day
AUC of Plasma Total GLP-1 Levels After Lunch
Time frame: every 30 minutes from noon to 4 p.m. on the second day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26839476Kim EK, Oh TJ, Kim LK, Cho YM. Improving Effect of the Acute Administration of Dietary Fiber-Enriched Cereals on Blood Glucose Levels and Gut Hormone Secretion. J Korean Med Sci. 2016 Feb;31(2):222-30. doi: 10.3346/jkms.2016.31.2.222. Epub 2016 Jan 26.
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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
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 dietary fiber-enriched cereal and conventional cereal 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 3 inclusion and 4 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 16 Nov 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 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?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC) of Plasma Total GLP-1 Levels After Intake of the Study Meal (time frame: every 30 minutes from 8 a.m. to noon on the second day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997281, which also lists 1 linked publication.
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 16 Nov 2020.