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IRCT20170916036204N8 IRCT 2020-03-03 Shiraz University of Medical Sciences Evaluating the Effect of Flaxseed on PCOS Evaluating the Effect of Flaxseed on Glycemic Indices, Lipid Profile, Hormones and Anthropometric Measurements on PCOS Patients 2020-01-20 anticipated 84 Complete https://irct.ir/trial/41841 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with fixed block size of four, Blinding description: The sachets presented to the control group are filled with colored rice powder, with the same appearance and packaging as those given to intervention group. So the patients do not recognize which of the two groups they are in. Also, the physician and the data analyst are unaware of this. 3 poly-cystic ovarian syndrome. Intervention 1: Intervention group: 30 grams of flax seed powder daily for 8 week in addition to weight loss diet and nutrition recommendations. Intervention 2: Control group: 30 grams of rice powder daily for 8 week in addition to weight loss diet and nutrition recommendations. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Zahra Moghdani
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 zahra.moghdani@gmail.com Shiraz University of Medical Sciences scientific Najmeh Hejazi
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 Nhejazi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Polycystic Ovarian Syndrome Based on Rotterdam Criteria By clinical practitioner 18 years 40 years Female Family history of breast, ovarian or uterine cancer Alcohol or drug use Pregnancy or lactation Use of anti-hypertension and lipid lowering drugs Metformin use 6 months before enrollment and during the study Diabetes, thyroid disease or any systemic disease (eg kidney, liver, digestive system, cardiovascular) Other disorders that lead to increased androgens in the blood (such as Cushing's syndrome, hyper prolactinemia) Menopause Use of drugs that affect glucose metabolism E28.2 Polycystic ovarian syndrome Treatment - Other Placebo Intervention group: 30 grams of flax seed powder daily for 8 week in addition to weight loss diet and nutrition recommendations Control group: 30 grams of rice powder daily for 8 week in addition to weight loss diet and nutrition recommendations ّFasting Blood Sugar. Timepoint: At the beginning and the end of the study (after 8 weeks ). Method of measurement: FBS kit. Insulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Insulin kit. Luteinizing Hormone. Timepoint: At the beginning and the end of the study (after 8 weeks ). Method of measurement: Luteinizing Hormone kit. Follicle-Stimulating Hormone. Timepoint: At the beginning and the end of the study (after 8 weeks ). Method of measurement: Follicle-Stimulating Hormone kit. Shiraz University of Medical Sciences Approved 2019-07-28 Ethics committee of Shiraz University of Medical Sciences Iran, Fars,Shiraz,Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)