Postprandial LipaemiaNCT00809874
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
A study testing Casein, Whey Isolate and Whey Hydrolysate in people with Postprandial Lipaemia and Postprandial Incretins, 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
- Postprandial Lipaemia, Postprandial Incretins, Postprandial Inflammation
- What is being tested?
- Casein, Whey Isolate and Whey Hydrolysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Dec 2008
- 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
- Casein, Whey Isolate, Whey Hydrolysate, Alphalact-Albumin
- Keywords
- Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins
- Medical subject headings
- Obesity, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseinDietary supplement
Whey IsolateDietary supplement
Whey HydrolysateDietary supplement
Alphalact-AlbuminDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Casein | Active comparator | Not described Receives: Dietary Supplement: Casein |
| Whey Isolate | Active comparator | Not described Receives: Dietary Supplement: Whey Isolate |
| Whey Hydrolysate | Active comparator | Not described Receives: Dietary Supplement: Whey Hydrolysate |
| Alphalact-Albumin | Active comparator | Not described Receives: Dietary Supplement: Alphalact-Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride
Measured: 0h- 1h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary outcomes (1)
Incretins
Measured: 0h -1h -2h -4h -6h -7h -8h Postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial LipaemiaStudies 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
- 11 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, Arla Foods
- Investigators
- K Hermansen, Professor, MD, Principal investigator, Department of Endocrinology and Metabolism, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809874
- Sponsor's protocol ID
- CERN-PPL-JHJ
- Status last verified
- Nov 2009
- First submitted
- 16 Dec 2008
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
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
- Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
- ClinicalTrials.gov ID
- NCT00809874
- Acronym / sponsor ID
- CERN-PPL-JHJ
- Keywords
- Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- The Danish Obesity Research Centre, Nordic Centre of Excellence, Arla Foods
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Dec 2008 (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
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Casein | Active comparator | Dietary Supplement: Casein |
| Whey Isolate | Active comparator | Dietary Supplement: Whey Isolate |
| Whey Hydrolysate | Active comparator | Dietary Supplement: Whey Hydrolysate |
| Alphalact-Albumin | Active comparator | Dietary Supplement: Alphalact-Albumin |
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 |
|---|---|---|
| Casein | Dietary supplement | Casein |
| Whey Isolate | Dietary supplement | Whey Isolate |
| Whey Hydrolysate | Dietary supplement | Whey Hydrolysate |
| Alphalact-Albumin | Dietary supplement | Alphalact-Albumin |
Primary outcome
Triglyceride
Time frame: 0h- 1h- 2h- 4h- 6h- 7h- 8h postprandial
1 secondary outcome
Incretins
Time frame: 0h -1h -2h -4h -6h -7h -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.
Related trials for Postprandial Lipaemia
Not yet recruiting
Effect of Standardized Large Yellow Tea Extract on Triglyceride Response After a High-Fat Meal in Healthy Adults
Postprandial Lipemia
Recruiting
The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome
Energy Expenditure, Metabolic Syndrome
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 Casein, Whey Isolate and Whey Hydrolysate in people with Postprandial Lipaemia and Postprandial Incretins, 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- 1h- 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?
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.