ObesityNCT00863564
Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
A study testing Caseine, Cod and Gluten in people with Obesity and Postprandial Lipemia, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal. Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Postprandial Lipemia, Atherosclerosis
- What is being tested?
- Caseine, Cod and Gluten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Oct 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 30 kg/m2 \& < 45 kg/m2
Who cannot join
- Diabetes
- Lipid lowering drugs
- Liver-, Kidney- and/or Heart Disease
- Serious Hypertension (160/110)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.
Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.
- Being tested
- Caseine, Cod, Gluten, Whey Isolate
- Keywords
- Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins, Postprandial inflammation
- Medical subject headings
- Obesity, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseineDietary supplement
CodDietary supplement
GlutenDietary supplement
Whey IsolateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Whey Isolate | Active comparator | Not described Receives: Dietary Supplement: Whey Isolate |
| Caseine | Active comparator | Not described Receives: Dietary Supplement: Caseine |
| 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
Measured: 0h- 2h- 4h- 6h- 8h postprandial
Secondary outcomes (2)
Incretins
Measured: 0h -1h -2h -4h -6h -8h Postprandial
Inflammatory markers
Measured: 0h- 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 posted18 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
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
- K Hermansen, Professor, MD, Principal investigator, Department of Endocrinology and Metabolism, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863564
- Sponsor's protocol ID
- CERN-PPL-JHJ-5a
- Status last verified
- Nov 2009
- First submitted
- 17 Mar 2009
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Holmer-Jensen J, Karhu T, Mortensen LS, Pedersen SB, Herzig KH, Hermansen K. Differential effects of dietary protein sources on postprandial low-grade inflammation after a single high fat meal in obese non-diabetic subjects. Nutr J. 2011 Oct 19;10:115. doi: 10.1186/1475-2891-10-115.
PubMed 22011432
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
- ClinicalTrials.gov ID
- NCT00863564
- Acronym / sponsor ID
- CERN-PPL-JHJ-5a
- Keywords
- Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- The Danish Obesity Research Centre, Nordic Centre of Excellence
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Mar 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.
The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.
Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Whey Isolate | Active comparator | Dietary Supplement: Whey Isolate |
| Caseine | Active comparator | Dietary Supplement: Caseine |
| Cod | Active comparator | Dietary Supplement: Cod |
| Gluten | Active comparator | Dietary Supplement: Gluten |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI > 30 kg/m2 \& < 45 kg/m2
Key exclusion criteria (4 listed)
- Diabetes
- Lipid lowering drugs
- Liver-, Kidney- and/or Heart Disease
- Serious Hypertension (160/110)
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 |
|---|---|---|
| Caseine | Dietary supplement | Caseine |
| Cod | Dietary supplement | Cod |
| Gluten | Dietary supplement | Gluten |
| Whey Isolate | Dietary supplement | Whey Isolate |
Primary outcome
Triglyceride
Time frame: 0h- 2h- 4h- 6h- 8h postprandial
2 secondary outcomes
Incretins
Time frame: 0h -1h -2h -4h -6h -8h Postprandial
Inflammatory markers
Time frame: 0h- 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 10 Nov 2009.
- Derived from this study: PubMed 22011432Holmer-Jensen J, Karhu T, Mortensen LS, Pedersen SB, Herzig KH, Hermansen K. Differential effects of dietary protein sources on postprandial low-grade inflammation after a single high fat meal in obese non-diabetic subjects. Nutr J. 2011 Oct 19;10:115. doi: 10.1186/1475-2891-10-115.
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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.
K Hermansen, Professor, MD principal investigator
Department of Endocrinology and Metabolism, Aarhus 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 Caseine, Cod and Gluten in people with Obesity 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 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 10 Nov 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 (time frame: 0h- 2h- 4h- 6h- 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 NCT00863564, 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 10 Nov 2009.