Polycystic Ovarian SyndromePCOSNCT00579540
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels
A study testing Flax Seed Oil, Fish Oil and Soybean Oil in people with Polycystic Ovarian Syndrome, run by University of California, Davis at 1 site in United States.
Trial summary
Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Flax Seed Oil, Fish Oil and Soybean Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females ages 18-45
- Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome
Who cannot join
- Use of oral contraceptives
- Impaired glucose tolerance
- Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
- Schizophrenia
- Having a pacemaker
- Current viral infection
- Smoking alcohol intake (more than 2 drinks/week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS
Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.
Read the detailed description
The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen secretion, in women with polycystic ovarian syndrome.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Flax Seed Oil, Fish Oil, Soybean Oil
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flax Seed OilDietary supplement
Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
Fish OilDietary supplement
Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
Soybean OilDietary supplement
Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. Receives: Dietary Supplement: Flax Seed Oil; Dietary Supplement: Fish Oil; Dietary Supplement: Soybean Oil |
| 2 | Active comparator | Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. Receives: Dietary Supplement: Flax Seed Oil; Dietary Supplement: Fish Oil; Dietary Supplement: Soybean Oil |
| 3 | Active comparator | Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. Receives: Dietary Supplement: Flax Seed Oil; Dietary Supplement: Fish Oil; Dietary Supplement: Soybean Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
We hope to learn more about the effects of fish oil, flax seed oil, and soybean oil, on blood sugar and insulin levels in PCOS patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Sidika Kasim-Karakas, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579540
- Sponsor's protocol ID
- 200715060
- Acronym
- PCOS
- Status last verified
- May 2017
- First submitted
- 17 Dec 2007
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS
- ClinicalTrials.gov ID
- NCT00579540
- Acronym / sponsor ID
- PCOS / 200715060
- Conditions
- Polycystic Ovarian Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Dec 2007 (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.
Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.
Detailed description
The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen secretion, in women with polycystic ovarian syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Flax Seed Oil, Dietary Supplement: Fish Oil, Dietary Supplement: Soybean OilSubject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. |
| 2 | Active comparator | Dietary Supplement: Flax Seed Oil, Dietary Supplement: Fish Oil, Dietary Supplement: Soybean OilSubject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. |
| 3 | Active comparator | Dietary Supplement: Flax Seed Oil, Dietary Supplement: Fish Oil, Dietary Supplement: Soybean OilSubject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females ages 18-45
- Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome
Key exclusion criteria (7 listed)
- Use of oral contraceptives
- Impaired glucose tolerance
- Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
- Schizophrenia
- Having a pacemaker
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 |
|---|---|---|
| Flax Seed OilSubject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks. | Dietary supplement | 1, 2, 3 |
| Fish OilSubject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks. | Dietary supplement | 1, 2, 3 |
| Soybean OilSubject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks. | Dietary supplement | 1, 2, 3 |
Primary outcome
We hope to learn more about the effects of fish oil, flax seed oil, and soybean oil, on blood sugar and insulin levels in PCOS patients
Time frame: 3 years
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 30 May 2017.
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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.
Sidika Kasim-Karakas, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flax Seed Oil, Fish Oil and Soybean Oil in people with Polycystic Ovarian Syndrome, run by University of California, Davis at 1 site in United States.
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 7 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 30 May 2017. 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 United States. 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?
We hope to learn more about the effects of fish oil, flax seed oil, and soybean oil, on blood sugar and insulin levels in PCOS patients (time frame: 3 years). 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 30 May 2017.