Polycystic Ovary SyndromeNCT02397174
Mediterranean Diet Versus Hypocaloric Diet in PCOS
A study testing mediterranean diet, restricted calorie and hypocaloric diet, restricted calorie in people with Polycystic Ovary Syndrome, run by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona at 1 site in Italy.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- mediterranean diet, restricted calorie and hypocaloric diet, restricted calorie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Jun 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria)
- BMI > 25
Who cannot join
- Age <18 or >35 years
- BMI higher than 35
- Pregnancy
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months
- Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fertility Techniques SSD,Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Salerno, 84131
Francesco Orio, MD, +39 338 6759977, francescoorio@virgilio.it
About this study
Official title: Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in PCOS women.
Read the detailed description
PCOS is the most common endocrine disorder of reproductive age women, that is often associated with chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. The new guidelines for the management of metabolic risk in PCOS strongly recommended that overweight/obese women with PCOS should lose weight changing their lifestyle. Although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested.
In this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- mediterranean diet, restricted calorie, hypocaloric diet, restricted calorie
- Keywords
- Polycystic Ovary syndrome, hypocaloric diet, Ovarian Cysts, Ovarian Diseases, Obesity, Mediterranean Diet
- Medical subject headings
- Polycystic Ovary Syndrome, Ovarian Cysts, Ovarian Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean diet, restricted calorieOther
50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
hypocaloric diet, restricted calorieOther
50 pcos women will be assigned to standardized hypocaloric diet for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet | Experimental | The diet programme will be characterized by carbohydrates (60 %); proteins (20 %, half comprised of vegetable proteins); total fat (20 %; saturated fat < 10 %). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day. Receives: Other: mediterranean diet, restricted calorie |
| hypocaloric diet | Active comparator | The diet programme will be characterized by carbohydrates (50%),total lipids (30%) and proteins (20%). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day. Receives: Other: hypocaloric diet, restricted calorie |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in insulin resistance measured by HOMA index
Measured: 6 months
Secondary outcomes (3)
composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio);
Measured: 6 months
composite improvement in metabolic parameters (total, LDL and HDL cholesterol);
Measured: 6 months
composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, University of Modena and Reggio Emilia
- Responsible party
- Principal investigator, Francesco Orio, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Investigators
- Francesco Orio, MD, Principal investigator, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397174
- Sponsor's protocol ID
- DIEMED1
- Status last verified
- Apr 2016
- First submitted
- 6 Mar 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
PubMed 18158291Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
PubMed 20858697
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Versus Hypocaloric Diet: What is the Best Choice for the Treatment of Polycystic Ovary Syndrome (PCOS)?
- ClinicalTrials.gov ID
- NCT02397174
- Acronym / sponsor ID
- DIEMED1
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary syndrome, hypocaloric diet, Ovarian Cysts, Ovarian Diseases, Obesity, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaUniversity, hospital or other
- Collaborators
- Federico II University, University of Modena and Reggio Emilia
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Mar 2015 (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) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in PCOS women.
Detailed description
PCOS is the most common endocrine disorder of reproductive age women, that is often associated with chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. The new guidelines for the management of metabolic risk in PCOS strongly recommended that overweight/obese women with PCOS should lose weight changing their lifestyle. Although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested.
In this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet | Experimental | Other: mediterranean diet, restricted calorieThe diet programme will be characterized by carbohydrates (60 %); proteins (20 %, half comprised of vegetable proteins); total fat (20 %; saturated fat < 10 %). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day. |
| hypocaloric diet | Active comparator | Other: hypocaloric diet, restricted calorieThe diet programme will be characterized by carbohydrates (50%),total lipids (30%) and proteins (20%). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria)
- BMI > 25
Key exclusion criteria (5 listed)
- Age <18 or >35 years
- BMI higher than 35
- Pregnancy
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months
- Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)
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 calorie50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months | Other | Mediterranean Diet |
| hypocaloric diet, restricted calorie50 pcos women will be assigned to standardized hypocaloric diet for 6 months | Other | hypocaloric diet |
Primary outcome
improvement in insulin resistance measured by HOMA index
Time frame: 6 months
3 secondary outcomes
composite improvement in clinical parameters (Body mass index, normalization of menses, hirsutism, waist to hip ratio);
Time frame: 6 months
composite improvement in metabolic parameters (total, LDL and HDL cholesterol);
Time frame: 6 months
composite improvement in hormonal parameters (Testosterone, Androstenedione, DHEAS, FSH, LH, beta estradiol)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Results publication: PubMed 18158291Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
- Results publication: PubMed 20858697Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.
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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.
Francesco Orio, MD principal investigator
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
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 hypocaloric diet, restricted calorie in people with Polycystic Ovary Syndrome, run by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona at 1 site in Italy.
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 5 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 19 Apr 2016. 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 Italy. 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?
Contact Francesco Orio, MD (+39 338 6759977, francescoorio@virgilio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in insulin resistance measured by HOMA index (time frame: 6 months). 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 NCT02397174, which also lists 2 linked publications.
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 19 Apr 2016.