Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-21 @ 11:00 PM
Study NCT ID:
NCT04163120
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2019-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Ketogenic Diet on PCOS Outcomes
Sponsor:
University of Padova
Organization:
Study Overview
Official Title:
Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.
Detailed Description:
Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score will be evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: