PostmenopauseNCT00901589
Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women
A study testing marine n-3 polyunsaturated fatty acids and thistle oil in people with Postmenopause and Premenopause, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause, Premenopause
- What is being tested?
- marine n-3 polyunsaturated fatty acids and thistle oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to May 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-70 years old
- healthy or well-treated chronic disease
Who cannot join
- hormone treatment
- foreseen compliance problem
- fish oil consumers
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for cardiovascular research, Aalborg Hospital
Aalborg, 9000
About this study
Official title: The Incorporation of Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women: a Randomized Double-Blinded Placebo-Controlled Clinical Trial
The study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure) blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs into tissues.
- Conditions
- Postmenopause, Premenopause
- Being tested
- marine n-3 polyunsaturated fatty acids, thistle oil
- Keywords
- n-3 PUFAs, menopause, adipose tissue, estrogens, Incorporation of fishoil in pre- and postmenopausal women, Marine n-3 PUFAs influence on female hormones in blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marine n-3 polyunsaturated fatty acidsDietary supplement
Also called Fish oil
Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total
thistle oilDietary supplement
four capsules a day
marine n-3 polyunsaturated fatty acidsDietary supplement
Also called Fish oil
Four capsules daily, 2.2 g marine n-3 PUFAs in total
Thistle oilDietary supplement
Four capsules daily
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women-fishoil | Active comparator | Not described Receives: Dietary Supplement: marine n-3 polyunsaturated fatty acids |
| Premenopausal-placebo | Placebo comparator | Not described Receives: Dietary Supplement: thistle oil |
| Postmenopausal women-fishoil | Active comparator | Not described Receives: Dietary Supplement: marine n-3 polyunsaturated fatty acids |
| Postmenopausal-placebo | Placebo comparator | Not described Receives: Dietary Supplement: Thistle oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention
Secondary outcomes (1)
Measurement of oestrogen concentrations in blood before and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- More trials run by Aalborg 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901589
- Sponsor's protocol ID
- Petra Witt
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incorporation of Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women: a Randomized Double-Blinded Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00901589
- Acronym / sponsor ID
- Petra Witt
- Conditions
- Postmenopause, Premenopause
- Keywords
- n-3 PUFAs, menopause, adipose tissue, estrogens, Incorporation of fishoil in pre- and postmenopausal women, Marine n-3 PUFAs influence on female hormones in blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 May 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 study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure) blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs into tissues.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women-fishoil | Active comparator | Dietary Supplement: marine n-3 polyunsaturated fatty acids |
| Premenopausal-placebo | Placebo comparator | Dietary Supplement: thistle oil |
| Postmenopausal women-fishoil | Active comparator | Dietary Supplement: marine n-3 polyunsaturated fatty acids |
| Postmenopausal-placebo | Placebo comparator | Dietary Supplement: Thistle oil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-70 years old
- healthy or well-treated chronic disease
Key exclusion criteria (3 listed)
- hormone treatment
- foreseen compliance problem
- fish oil consumers
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 |
|---|---|---|
| marine n-3 polyunsaturated fatty acidsAlso: Fish oilFour capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total | Dietary supplement | Premenopausal women-fishoil |
| thistle oilfour capsules a day | Dietary supplement | Premenopausal-placebo |
| marine n-3 polyunsaturated fatty acidsAlso: Fish oilFour capsules daily, 2.2 g marine n-3 PUFAs in total | Dietary supplement | Postmenopausal women-fishoil |
| Thistle oilFour capsules daily | Dietary supplement | Postmenopausal-placebo |
Primary outcome
Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention
1 secondary outcome
Measurement of oestrogen concentrations in blood before and after intervention
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 14 May 2009.
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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 marine n-3 polyunsaturated fatty acids and thistle oil in people with Postmenopause and Premenopause, run by Aalborg 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 2 inclusion and 3 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 14 May 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. 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?
Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention. 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 14 May 2009.