Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03713138 |
| Other study ID # |
6099 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2017 |
| Est. completion date |
January 1, 2018 |
Study information
| Verified date |
October 2018 |
| Source |
Allied Hospital Faisalabad |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
