Polycystic Ovary SyndromeFEMINNCT00779571
The Female Health Dietary Intervention Study
A study testing Crispbread in people with Polycystic Ovary Syndrome and Morbid Obesity, run by The Hospital of Vestfold at 1 site in Norway.
Trial summary
This study has two phases: 1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared. 2. Read more about this study
- Who is it for?
- Ages 19 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Morbid Obesity
- What is being tested?
- Crispbread
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2008to Feb 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 19 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman (European Caucasian)
- PCOS
- BMI = or > 35
Who cannot join
- Cushing syndrome
- Adrenal hyperplasia
- Androgen-producing tumors
- Anovulation caused by hyperprolactinemia
- Pregnancy, breast feeding
- Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
This study has two phases:
- In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
- In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.
Read the detailed description
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
- Conditions
- Polycystic Ovary Syndrome, Morbid Obesity
- Being tested
- Crispbread
- Keywords
- Polycystic Ovary Syndrome, Morbid Obesity, Type 2 DM, Coronary heart disease
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Morbid, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrispbreadBehavioural
8 week low calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Crispbread | Experimental | Intervention: Crispbread LCD Receives: Behavioral: Crispbread |
| Liquid meal replacement | Active comparator | Intervention: LMR LCD Receives: Behavioral: Crispbread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: One year
Secondary outcomes (1)
Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionFeb 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 Polycystic Ovary SyndromeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Line Kristin Johnson, The Hospital of Vestfold
- Investigators
- Jøran Hjelmesæth, MD, PhD, Principal investigator, The Hospital of VestfoldTom Tanbo, MD, PhD, Study chair, Oslo University HospitalKirsten B Holven, PhD, Principal investigator, University of OsloLine Kristin Johnson, MSc, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779571
- Sponsor's protocol ID
- 86-814d 6.2008.453
- Acronym
- FEMIN
- Status last verified
- Oct 2014
- First submitted
- 22 Oct 2008
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesaeth J. Fructose content of low calorie diets: effect on cardiometabolic risk factors in obese women with polycystic ovarian syndrome: a randomized controlled trial. Endocr Connect. 2015 Sep;4(3):144-54. doi: 10.1530/EC-15-0047.
PubMed 26138702
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT00779571
- Acronym / sponsor ID
- FEMIN / 86-814d 6.2008.453
- Conditions
- Polycystic Ovary Syndrome, Morbid Obesity
- Keywords
- Polycystic Ovary Syndrome, Morbid Obesity, Type 2 DM, Coronary heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 24 Oct 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.
This study has two phases:
- In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
- In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.
Detailed description
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crispbread | Experimental | Behavioral: CrispbreadIntervention: Crispbread LCD |
| Liquid meal replacement | Active comparator | Behavioral: CrispbreadIntervention: LMR LCD |
Who may qualify
- Ages
- 19 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Woman (European Caucasian)
- PCOS
- BMI = or > 35
Key exclusion criteria (6 listed)
- Cushing syndrome
- Adrenal hyperplasia
- Androgen-producing tumors
- Anovulation caused by hyperprolactinemia
- Pregnancy, breast feeding
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 |
|---|---|---|
| Crispbread8 week low calorie diet | Behavioural | Crispbread, Liquid meal replacement |
Primary outcome
Weight loss
Time frame: One year
1 secondary outcome
Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors
Time frame: one year
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 Oct 2014.
- Derived from this study: PubMed 26138702Johnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesaeth J. Fructose content of low calorie diets: effect on cardiometabolic risk factors in obese women with polycystic ovarian syndrome: a randomized controlled trial. Endocr Connect. 2015 Sep;4(3):144-54. doi: 10.1530/EC-15-0047.
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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.
Jøran Hjelmesæth, MD, PhD principal investigator
The Hospital of Vestfold
Tom Tanbo, MD, PhD study chair
Oslo University Hospital
Kirsten B Holven, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crispbread in people with Polycystic Ovary Syndrome and Morbid Obesity, run by The Hospital of Vestfold at 1 site in Norway.
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 3 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 10 Oct 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 Norway. 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?
Weight loss (time frame: One year). 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 NCT00779571, 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 Oct 2014.