HypertriglyceridemiaNCT01437930
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
A study testing n-3 PUFA in people with Hypertriglyceridemia, run by University of Jena at 1 site in Germany.
Trial summary
The study was performed to investigate the effects of a daily consumption of n-3 PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- n-3 PUFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Apr 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L
Who cannot join
- Lipid lowering medications
- Glucocorticoids
- Gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
- Daily alcohol abuse
- Taking dietary supplements (e. g., fish oil capsules, vitamin E)
- Known allergies or foodstuff indigestibility
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University, Institute of Nutrition
Jena, 07743
About this study
Official title: Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
The study was performed to investigate the effects of a daily consumption of n-3 PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients.
Read the detailed description
Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart diseases.
As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination by their general practitioners. Sixty hypertriglyceridemic patients (with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) should entered the study.
The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 10 weeks. Patients in the placebo period receive 60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. These products were enriched with sunflower oil (20g/d).
In the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil, and c)12g microalgae powder. The daily dose of special n-3 fatty acid amounted to a) 10g alpha linolenic acid (ALA), b 2g stearidonic acid (SDA)+6g ALA, or c) 2g docosahexaenoic acid (DHA).
Venous blood is collected at the beginning and at the end of each period.
- Conditions
- Hypertriglyceridemia
- Being tested
- n-3 PUFA
- Keywords
- n-3 LC-PUFA, hypertriglyceridemic, human, TAG
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFADietary supplement
products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder
- linseed oil (20g/d)(PPM, Magdeburg)
- echium oil (20g/d) (HARKE Nutrition)
- microalgae powder(12g/d)(HARKE Nutrition)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | products (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d Receives: Dietary Supplement: n-3 PUFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
Measured: 10 weeks
Secondary outcomes (7)
blood pressure
Measured: 10 weeks
high sensitive C-reactive protein
Measured: 10 weeks
oxidised LDL
Measured: 10 weeks
lipoprotein a
Lipoprotein(a)
Measured: 10 weeks
vascular cell adhesion molecule
vascular cell adhesion molecule
Measured: 10 weeks
intracellular adhesion molecule
intracellular cell adhesion molecule
Measured: 10 weeks
fatty acid distribution in plasma lipids and erythrocyte membranes
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionApr 2012
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 HypertriglyceridemiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437930
- Sponsor's protocol ID
- H51_11
- Status last verified
- Mar 2012
- First submitted
- 19 Sep 2011
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dittrich M, Jahreis G, Bothor K, Drechsel C, Kiehntopf M, Bluher M, Dawczynski C. Benefits of foods supplemented with vegetable oils rich in alpha-linolenic, stearidonic or docosahexaenoic acid in hypertriglyceridemic subjects: a double-blind, randomized, controlled trail. Eur J Nutr. 2015 Sep;54(6):881-93. doi: 10.1007/s00394-014-0764-2. Epub 2014 Sep 13.
PubMed 25216712
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT01437930
- Acronym / sponsor ID
- H51_11
- Conditions
- Hypertriglyceridemia
- Keywords
- n-3 LC-PUFA, hypertriglyceridemic, human, TAG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Sep 2011 (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 study was performed to investigate the effects of a daily consumption of n-3 PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients.
Detailed description
Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart diseases.
As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination by their general practitioners. Sixty hypertriglyceridemic patients (with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) should entered the study.
The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 10 weeks. Patients in the placebo period receive 60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. These products were enriched with sunflower oil (20g/d).
In the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil, and c)12g microalgae powder. The daily dose of special n-3 fatty acid amounted to a) 10g alpha linolenic acid (ALA), b 2g stearidonic acid (SDA)+6g ALA, or c) 2g docosahexaenoic acid (DHA).
Venous blood is collected at the beginning and at the end of each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: n-3 PUFAproducts (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L
Key exclusion criteria (6 listed)
- Lipid lowering medications
- Glucocorticoids
- Gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
- Daily alcohol abuse
- Taking dietary supplements (e. g., fish oil capsules, vitamin E)
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 |
|---|---|---|
| n-3 PUFAproducts (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder 1. linseed oil (20g/d)(PPM, Magdeburg) 2. echium oil (20g/d) (HARKE Nutrition) 3. microalgae powder(12g/d)(HARKE Nutrition) | Dietary supplement | placebo |
Primary outcome
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
Time frame: 10 weeks
7 secondary outcomes
blood pressure
Time frame: 10 weeks
high sensitive C-reactive protein
Time frame: 10 weeks
oxidised LDL
Time frame: 10 weeks
lipoprotein a
Time frame: 10 weeks
vascular cell adhesion molecule
Time frame: 10 weeks
intracellular adhesion molecule
Time frame: 10 weeks
fatty acid distribution in plasma lipids and erythrocyte membranes
Time frame: 10 weeks
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 29 Jul 2014.
- Derived from this study: PubMed 25216712Dittrich M, Jahreis G, Bothor K, Drechsel C, Kiehntopf M, Bluher M, Dawczynski C. Benefits of foods supplemented with vegetable oils rich in alpha-linolenic, stearidonic or docosahexaenoic acid in hypertriglyceridemic subjects: a double-blind, randomized, controlled trail. Eur J Nutr. 2015 Sep;54(6):881-93. doi: 10.1007/s00394-014-0764-2. Epub 2014 Sep 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 PUFA in people with Hypertriglyceridemia, run by University of Jena at 1 site in Germany.
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 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 29 Jul 2014. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG) (time frame: 10 weeks). 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 NCT01437930, 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 29 Jul 2014.