Comparison Between Mediterranean Diet and High Protein Diet in Women With Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFebruary 20, 2013
February 1, 2013
7 months
June 7, 2012
February 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement in metabolic outcomes of women with pcos
18 months
Secondary Outcomes (1)
improvement in clinical symptoms: acne, hirsutism and menstrual regularity
18 months
Study Arms (2)
mediterranean diet restricted calorie
EXPERIMENTAL1500 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
EXPERIMENTAL1500 k/calories 40 % carbohydrate 30% protein 30% fat
Interventions
50 pcos diagnosed women will be assigned to high protein diet for 18 month
Eligibility Criteria
You may qualify if:
- Polycystic ovary syndrome
You may not qualify if:
- 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
- Chronic disease - kidney/heart/diabetes/lung
- Psychiatric disease
- Drug use accept contraceptive pills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clalit Health Services
Haifa, Israel, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Geva, MD
Clalit Health Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 11, 2012
Study Start
April 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
February 20, 2013
Record last verified: 2013-02