Diabetes MellitusNCT01678742
Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
A study testing High-protein diet and Standard diet in people with Diabetes Mellitus and Obesity, run by Jeju National University Hospital at 1 site in South Korea.
Trial summary
The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- High-protein diet and Standard diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Apr 2013
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus
- Subjects signed a written informed consent form
Who cannot join
- Liver cirrhosis
- Chronic renal disease (serum creatinine > 2mg/dL)
- Severe congestive heart failure
- Significant infectious or inflammatory diseases
- intractable malignant neoplasm
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- High-protein diet, Standard diet
- Keywords
- Diet, Incretins, Gastrointestinal Hormones, Fish Proteins
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-protein dietDietary supplement
Also called A Jeju red horsehead fish-based meal
The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.
A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.
Standard dietDietary supplement
Also called A mixed meal
The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.
| Study group | Role | What they receive |
|---|---|---|
| High-protein diet | Experimental | Not described Receives: Dietary Supplement: High-protein diet |
| Standard diet | Active comparator | Not described Receives: Dietary Supplement: Standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
Measured: 3 hours
Secondary outcomes (4)
Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
Measured: 3 hours
Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
Measured: 3 hours
Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
Measured: 3 hours
Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
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.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeju National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwanpyo Koh, Jeju National University Hospital
- Investigators
- Gwanpyo Koh, Professor, Principal investigator, Jeju National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678742
- Sponsor's protocol ID
- 2012-06-007-002
- Other IDs
- C0038345
- Status last verified
- Mar 2015
- First submitted
- 25 Aug 2012
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
- ClinicalTrials.gov ID
- NCT01678742
- Acronym / sponsor ID
- 2012-06-007-002
- Conditions
- Diabetes Mellitus, Obesity
- Keywords
- Diet, Incretins, Gastrointestinal Hormones, Fish Proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jeju National University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Sep 2012 (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 our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein diet | Experimental | Dietary Supplement: High-protein diet |
| Standard diet | Active comparator | Dietary Supplement: Standard diet |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus
- Subjects signed a written informed consent form
Key exclusion criteria (6 listed)
- Liver cirrhosis
- Chronic renal disease (serum creatinine > 2mg/dL)
- Severe congestive heart failure
- Significant infectious or inflammatory diseases
- intractable malignant neoplasm
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 |
|---|---|---|
| High-protein dietAlso: A Jeju red horsehead fish-based mealThe high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal. A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea. | Dietary supplement | High-protein diet |
| Standard dietAlso: A mixed mealThe standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal. | Dietary supplement | Standard diet |
Primary outcome
Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups
Time frame: 3 hours
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
4 secondary outcomes
Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups
Time frame: 3 hours
Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups
Time frame: 3 hours
Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups
Time frame: 3 hours
Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups
Time frame: 3 hours
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 2 Apr 2015.
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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.
Gwanpyo Koh, Professor principal investigator
Jeju National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-protein diet and Standard diet in people with Diabetes Mellitus and Obesity, run by Jeju 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 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 2 Apr 2015. 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?
Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups (time frame: 3 hours). 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 2 Apr 2015.