Type 2 DiabetesNCT00817973
Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein
A study testing Casein, Whey and Cod in people with Type 2 Diabetes and Postprandial Lipemia, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Postprandial Lipemia
- What is being tested?
- Casein, Whey and Cod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes
Who cannot join
- Liver, Kidney- and/or Heart Disease
- Serious Hypertension (160/110 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.
The purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.
- Conditions
- Type 2 Diabetes, Postprandial Lipemia
- Being tested
- Casein, Whey, Cod, Gluten
- Keywords
- Whey protein, gluten, casein, cod protein, GLP-1, postprandial, triglyceride, free fatty acids, chylomicrons, retinyl palmitate, type 2 diabetes, GIP, Postprandial incretins
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseinDietary supplement
WheyDietary supplement
CodDietary supplement
GlutenDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Casein | Active comparator | Not described Receives: Dietary Supplement: Casein |
| Whey | Active comparator | Not described Receives: Dietary Supplement: Whey |
| Cod | Active comparator | Not described Receives: Dietary Supplement: Cod |
| Gluten | Active comparator | Not described Receives: Dietary Supplement: Gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride levels
Measured: 0h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary outcomes (1)
Incretin levels
Measured: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Aarhus 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Obesity Research Centre, Nordic Centre of Excellence
- Investigators
- Kjeld Hermansen, Professor, MD, Principal investigator, Department of Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817973
- Sponsor's protocol ID
- CERN-PPL (5A) LSM
- Status last verified
- Jan 2009
- First submitted
- 6 Jan 2009
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mortensen LS, Thomsen C, Hermansen K. Effects of different protein sources on plasminogen inhibitor-1 and factor VII coagulant activity added to a fat-rich meal in type 2 diabetes. Rev Diabet Stud. 2010 Fall;7(3):233-40. doi: 10.1900/RDS.2010.7.233. Epub 2010 Nov 10.
PubMed 21409315Mortensen LS, Hartvigsen ML, Brader LJ, Astrup A, Schrezenmeir J, Holst JJ, Thomsen C, Hermansen K. Differential effects of protein quality on postprandial lipemia in response to a fat-rich meal in type 2 diabetes: comparison of whey, casein, gluten, and cod protein. Am J Clin Nutr. 2009 Jul;90(1):41-8. doi: 10.3945/ajcn.2008.27281. Epub 2009 May 20.
PubMed 19458012
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein
- ClinicalTrials.gov ID
- NCT00817973
- Acronym / sponsor ID
- CERN-PPL (5A) LSM
- Conditions
- Type 2 Diabetes, Postprandial Lipemia
- Keywords
- Whey protein, gluten, casein, cod protein, GLP-1, postprandial, triglyceride, free fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- The Danish Obesity Research Centre, Nordic Centre of Excellence
- First posted
- 7 Jan 2009 (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.
Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.
The purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Casein | Active comparator | Dietary Supplement: Casein |
| Whey | Active comparator | Dietary Supplement: Whey |
| Cod | Active comparator | Dietary Supplement: Cod |
| Gluten | Active comparator | Dietary Supplement: Gluten |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes
Key exclusion criteria (2 listed)
- Liver, Kidney- and/or Heart Disease
- Serious Hypertension (160/110 mmHg)
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 |
|---|---|---|
| Casein | Dietary supplement | Casein |
| Whey | Dietary supplement | Whey |
| Cod | Dietary supplement | Cod |
| Gluten | Dietary supplement | Gluten |
Primary outcome
Triglyceride levels
Time frame: 0h- 2h- 4h- 6h- 7h- 8h postprandial
1 secondary outcome
Incretin levels
Time frame: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial
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 9 Jan 2009.
- Derived from this study: PubMed 21409315Mortensen LS, Thomsen C, Hermansen K. Effects of different protein sources on plasminogen inhibitor-1 and factor VII coagulant activity added to a fat-rich meal in type 2 diabetes. Rev Diabet Stud. 2010 Fall;7(3):233-40. doi: 10.1900/RDS.2010.7.233. Epub 2010 Nov 10.
- Derived from this study: PubMed 19458012Mortensen LS, Hartvigsen ML, Brader LJ, Astrup A, Schrezenmeir J, Holst JJ, Thomsen C, Hermansen K. Differential effects of protein quality on postprandial lipemia in response to a fat-rich meal in type 2 diabetes: comparison of whey, casein, gluten, and cod protein. Am J Clin Nutr. 2009 Jul;90(1):41-8. doi: 10.3945/ajcn.2008.27281. Epub 2009 May 20.
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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.
Kjeld Hermansen, Professor, MD principal investigator
Department of Endocrinology and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein, Whey and Cod in people with Type 2 Diabetes and Postprandial Lipemia, run by Aarhus University Hospital at 1 site in Denmark.
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 1 inclusion and 2 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 9 Jan 2009. 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 Denmark. 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?
Triglyceride levels (time frame: 0h- 2h- 4h- 6h- 7h- 8h postprandial). 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 NCT00817973, which also lists 2 linked publications.
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 Jan 2009.