Polycystic Ovary SyndromeNCT01615848
Comparison Between Mediterranean Diet and High Protein Diet in Women With Polycystic Ovary Syndrome (PCOS)
A study testing mediterranean diet restricted calorie and high protein diet in people with Polycystic Ovary Syndrome, run by Meir Medical Center at 1 site in Israel.
Trial summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- mediterranean diet restricted calorie and high protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Nov 2013
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic ovary syndrome
Who cannot join
- Pregnancy
- Lactation 6 month prior to study
- Known hyperandrogenism
- More then 5 kg weight loss 6 month prior to study
- Imbalance pituitary hormones
- Alcohol or drug abuse
Show all 9Show fewer
- Chronic disease - kidney/heart/diabetes/lung
- Psychiatric disease
- Drug use accept contraceptive pills
Trial locations and contacts
1 site in 1 country.
Israel1 site
Clalit Health Services
Haifa, Israel
Adam Geva, MD, 052-3562580, hadasha@clalit.org.il
Hadas Hardoon, B.Sc.Nutr
About this study
Official title: Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial
Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance.
Low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown.
In this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- mediterranean diet restricted calorie, high protein diet
- Keywords
- polycystic Ovary syndrome (PCOS), diet, mediterranean diet, high protein diet
- 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.
mediterranean diet restricted calorieOther
1500 k/cal 30% fat
high protein dietOther
50 pcos diagnosed women will be assigned to high protein diet for 18 month
mediterranean diet restricted calorieOther
50 pcos women will be assigned to 1500 k/cal diet for 18 month
| Study group | Role | What they receive |
|---|---|---|
| mediterranean diet restricted calorie | Experimental | 1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated \& polyunsaturated fat Receives: Other: mediterranean diet restricted calorie |
| high protein diet, restricted calorie | Experimental | 1500 k/calories 40 % carbohydrate 30% protein 30% fat Receives: Other: high protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in metabolic outcomes of women with pcos
Measured: 18 months
Secondary outcomes (1)
improvement in clinical symptoms: acne, hirsutism and menstrual regularity
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Geva, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615848
- Sponsor's protocol ID
- MMC12043-20kCTIL
- Status last verified
- Feb 2013
- First submitted
- 7 Jun 2012
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Mediterranean Diet and High Protein Diet in Women With Pcos: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01615848
- Acronym / sponsor ID
- MMC12043-20kCTIL
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic Ovary syndrome (PCOS), diet, mediterranean diet, high protein diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 11 Jun 2012 (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.
Polycystic ovary syndrome (PCOS) affects 5-10% of women and is the most common endocrine syndrome.PCOS is associated with infertility, risk for obesity and type 2 diabetes. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. restricted calorie High protein diet and mediterranean diet may improve insulin sensitivity and therefore lower androgen production in women with pcos women.the purpose of this study is to determine which diet is more effective in improving metabolic and reproductive outcomes.
Detailed description
Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating excess androgen production hence causing an hormonal imbalance.
Low calories diets have shown to improve pcos symptoms but the optimal diet for all pcos women is still unknown.
In this study, our purpose is to compare two lowering insulin restricted calories diets in order to find the optimal diet for improving metabolic and endocrin outcomes in pcos women we will also investigate which diet has the best long lasting compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mediterranean diet restricted calorie | Experimental | Other: mediterranean diet restricted calorie1500 k/calories 47-51% carbohydrate 14-17% protein 33-36% fat: 7-7.6% saturated fat 22-30% monounsaturated \& polyunsaturated fat |
| high protein diet, restricted calorie | Experimental | Other: high protein diet1500 k/calories 40 % carbohydrate 30% protein 30% fat |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Polycystic ovary syndrome
Key exclusion criteria (9 listed)
- Pregnancy
- Lactation 6 month prior to study
- Known hyperandrogenism
- More then 5 kg weight loss 6 month prior to study
- Imbalance pituitary hormones
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 |
|---|---|---|
| mediterranean diet restricted calorie1500 k/cal 30% fat | Other | mediterranean diet restricted calorie |
| high protein diet50 pcos diagnosed women will be assigned to high protein diet for 18 month | Other | high protein diet, restricted calorie |
| mediterranean diet restricted calorie50 pcos women will be assigned to 1500 k/cal diet for 18 month | Other | mediterranean diet restricted calorie |
Primary outcome
improvement in metabolic outcomes of women with pcos
Time frame: 18 months
1 secondary outcome
improvement in clinical symptoms: acne, hirsutism and menstrual regularity
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
Adam Geva, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean diet restricted calorie and high protein diet in people with Polycystic Ovary Syndrome, run by Meir Medical Center at 1 site in Israel.
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 9 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: status not confirmed, as of the sponsor's last update on 20 Feb 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in metabolic outcomes of women with pcos (time frame: 18 months). 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 20 Feb 2013.