Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome
Condition: Poly Cystic Ovary Syndrome
MeSH terms: Ovarian Cysts; Syndrome
Study type: Interventional

Summary: 
      The study was conducted to determine the therapeutic role of flax seed for Poly cystic ovary
      syndrome. A sample of 100 subjects were collected. The subjects were from various age group
      ranging from 18 to 45 years. Subjects showing the signs, symptoms, biochemical, and clinical
      parameters of the diseases were included in the study. Three different quantities of flax
      seed were introduced to the subjects for 90 days.

      Objectives:

        1. To assess the nutritional status of Poly cystic Ovary Syndrome patients

        2. To determine the therapeutic role of flax seed for PCOS patients

      Material and method: The level of follicle stimulating hormone, leutinizing hormone, sex
      hormone binding globulin, serum prolactin, ultrasound were analyzed. To determine the side
      effects of the flax seed, the liver-enzymatic, lipid profile, and renal tests were conducted.
    

Detailed description: 
      Material and methods

      Study Population:

      The data were collected from the Allied Hospital. All Females of ages 18 to 45 years, having
      PCOS attending the OPD of Allied Hospital was taken as the study population. Efficacy trials
      were conducted on the patients of PCOS, including females of age 18-45 years. They were
      divided into different groups (as per no. of selected treatments along with the control). Ten
      subjects left the study and were replaced. The project was approved by the ethical review
      committee.The feeding study was conducted with the cooperation of Allied Hospital. The study
      protocol was discussed with medical professionals and finalized after through technical
      suggestions.

      Selection of subjects and Study Design

      The patients were assorted randomly into four groups, 25 in each, namely control (T0),

      A total 100 female subjects were included in the study as under A) Control: To: 25 B)
      Experimental groups (PCOS): 75

        1. T1: 25

        2. T2: 25

        3. T3: 25

      Inclusion Criteria:

      All females of age 18 to 45 having PCOS

      Women showing the presence of two out of three features (Oligo- or anovulation,
      hyper-androgenism, or poly cystic ovaries (Ovarian volume >10cc, 12 or more peripherally
      located follicles 2-9 mm in diameter or hypo-echoic enlarged ovaries with hyper-echoic
      central stroma in USG). Patients on Metformin (used for insulin resistance)

      Exclusion Criteria:

        -  Females under 18 and above 45 years of age

        -  Those on any other medical therapy

        -  Pregnant and lactating women

        -  Those with a history of allergy to flax seed

        -  Women on anti-platelet and fibrinolytic drugs

        -  Women showing signs of PCOS but showing normal ovaries on ultrasound

      Study Design

      It was literature review based intervention study. The selected population for intervention
      purposes was studied twice, i.e. before and after the intervention of the selected
      nutraceutical. The same subjects were studied once again after one month of stopping the
      intake of selected nutraceutical. The change in results has confirmed the effects of the
      intervention.

      This has been divided into four phases.

        1. Phase-1:Assessment of the nutritional Status in PCOS

        2. Phase -2:Development of nutraceutical (flaxseed sachets)

        3. Phase -3:Intervention to study the effect of selected nutraceutical

        4. Phase-4:Blood Analysis

           The procedure adopted in each of the above phases is explained as follows:

           Phase-1: Assessment of the nutritional status of selected patients

           This was done in Allied Hospital, patients attending OPD of gynecology ward was assessed
           for nutritional status. Following parameters were studied for this purpose

             -  Family History

             -  Medical history

             -  Physical signs (thyroid gland, height, weight, skin, hair, breasts, belly, and BMI)

             -  Menstrual cycle detail (menarche, frequency, duration, and severity)

             -  History of dysmenorrhea

             -  Ferriman-Gall way scoring for hirsutism

             -  Marital status, parity, and difficulty in conception

           Phase -2: Development of Nutraceutical (flaxseed sachets)

           Procurement of raw materials Preparation of flax seed powder Preparation of flax seed
           sachets

           Phase-3: Intervention

           An acceptable number of human volunteers were selected keeping in view all ethical
           considerations. (25 in each group)

             1. Control group (To)

             2. Flaxseed (5 g) xTTS = 15 g/day (T1)

             3. Flaxseed (6.6 g) x TTS = 20 g/day (T2)

             4. Flaxseed (8.3 g) xTTS = 25 g/day (T3)

           The flaxseed powder from the selected treatments was given daily for a period of 12
           weeks. The dietary history of the subjects was monitored with the help of a Food Diary
           on a weekly basis. Education/counselling were provided to the patients for necessary
           compliance with the restricted diet for PCOS.

           Phase-4: Blood Analysis and Ultrasound

           After three months of intervention blood tests: follicle stimulating hormone (FSH),
           Luteinizing hormone (LH) thyroid stimulating hormone (TSH), serum prolactin, and
           ultrasound will be repeated.

           Biochemical assays

           Follicles stimulating hormone

           The blood sample was taken to determine the quantitative level of serum follicles
           stimulating hormone (FSH) in patients fed with flaxseed powder by following the
           Immuno-enzymatic calorimetric method (ELISA).

           Luteinizing hormone

           The blood sample was taken to determine the quantitative level of serum luteinizing
           hormone (LH) in patients fed with flaxseed powder by following the Immuno-enzymatic
           calorimetric method.

           Sex hormone binding globulin

           The serum sex hormone binding globulin hormone (SHBG) in patients fed with flaxseed
           powder was determined by following the Rosner's method.

           Prolactin

           The serum sex prolactin level in patients fed with flaxseed powder was determined by
           following the radio-immunological method.

           Thyroid stimulating hormone

           The thyroid stimulating hormone (TSH) level in patients fed with flaxseed powder was
           performed to determine the thyroid gland functioning by following the third-generation
           non-isotopic method.

           Liver Function Test

           Alkaline Phosphatase (ALP)

           The activity of alanine phosphatase in the plasma was determined by using enzyme-linked
           immune-sorbent assay kit method.

           Aspartate Aminotransferase (AST)

           The activity alanine transferase in the plasma was determined by using di-nitrophenyl
           hydrazine (DNPH) method using Sigma kits 59-50 and 58-50 under the conditions.

           Alanine Aminotransferase (ALT)

           The activity alanine aminotransferase in the plasma was determined by using
           enzyme-linked immune-sorbent assay kit method.

           Lipid Profile

           Low-density lipoprotein (LDL)

           Serum low-density lipoprotein (LDL) was estimated by following the protocol of Vinson.

           High-density lipoprotein (HDL)

           The high-density lipoprotein (HDL) was assessed by HDL-Cholesterol precipitation.

           Triglyceride

           The triglyceride in the collected serum was determined by liquid triglyceride (GPO-PAP)
           method.

           Renal Function Tests

           Urea

           The flax seed fed patients were diagnosed with urea content by GLDH method with the help
           of commercial kit.

           Creatinine

           The blood creatinine of the patients fed on flax seed powder was determined by the Jaffe
           method using creatinine commercial kit.

           Follicles present in ovaries

           Ultrasound of the ovaries was carried out to check the number of follicles present in
           the ovaries.

           Size of the ovaries

           The size of the ovaries of patients fed with flax seed powder was also checked in
           ultrasound.

           Fasting blood glucose level

           The blood sample was taken to check the fasting blood glucose level. The sample was
           taken eight hours after eating. Fasting blood glucose level as determined by glucose dye
           oxido-reductase mediator reaction which is specific for glucose by glucometer Accuchek
           active.

           Research instruments

             1. Questionnaire: For screening/nutritional assessment of PCOS patients

             2. Hormonal analysis: Follicle stimulating hormone (FSH), luteinizing hormone (LH)
                thyroid stimulating hormone (TSH), Sex Hormone binding globulin (SHBG), and serum
                prolactin.

             3. Biochemical assay: ALP, ALT, AST, urea, Creatinine, Fasting blood glucose level,
                LDL, HDL, and triglyceride.

           Ethical Considerations:Written ethical approval was taken from the management of the
           concerned hospital and HOD of Gynecology department of the selected hospital. The
           consent was taken from the subjects after explaining the purpose of the study and after
           getting their consent for their menstrual cycle history, blood tests and ultrasound.

           Statistical analysis

           The data were subjected to statistical analysis by using the SPSS statistical package,
           analysis of variance (ANOVA) and least significant difference (LSD) was used to
           determine any significant difference among the treatments at p<0.05.
    

Intervention name(s): flaxseed powder
Intervention type(s): Dietary Supplement
Intervention description(s): Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.
Other intervention name(s): Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled placebo trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Follicle stimulating hormone; Leutinizing hormone; Sex hormone binding globulin; Serum Prolactin; Flaxseed sachets; Lipid profile