NCT03713138

Brief 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. 1.To assess the nutritional status of Poly cystic Ovary Syndrome patients
  2. 2.To determine the therapeutic role of flax seed for PCOS patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 23, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 13, 2018

Last Update Submit

October 19, 2018

Conditions

Poly Cystic Ovary Syndrome

Keywords

Follicle stimulating hormoneLeutinizing hormoneSex hormone binding globulinSerum ProlactinFlaxseed sachetsLipid profile

Outcome Measures

Primary Outcomes (4)

  • Follicle stimulating hormone (mIU/MI)

    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).

    3 months

  • Leutinizing Hormone (mIU/MI)

    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 (ELISA-ALPCO)

    3 months

  • Sex hormone binding globulin (mg/dL)

    The serum sex hormone binding globulin hormone (SHBG) in patients fed with flaxseed powder was determined by following the Rosner's method.

    3 months

  • Serum Prolactin (ng/ml)

    The serum sex prolactin level in patients fed with flaxseed powder was determined by following the radio-immunological method.

    3 months

Secondary Outcomes (2)

  • blood sugar fasting (mg/dL)

    3 months

  • Thyroid stimulating hormone (Ml/L)

    3 months

Study Arms (2)

Intervention Flaxseed powder

EXPERIMENTAL

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. Intervention/ Dietary Supplement: Flax seed powder 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 Name: intervention

Dietary Supplement: flaxseed powder

Control group; Comparison group

NO INTERVENTION

The controlled group was given no intervention. No intervention was done to this group. Three different quantities of white flour were intervened to the subjects. One group was given 15 grams of white flour a day. Second group was given 20 grams and third group was given 25 grams of white flour a day.

Interventions

flaxseed powderDIETARY_SUPPLEMENT

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.

Also known as: Intervention
Intervention Flaxseed powder

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 polycystic 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)

You may not qualify if:

  • 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 flaxseed
  • Women on antiplatelet and fibrinolytic drugs
  • Women showing signs of PCOS but showing normal ovaries on ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allama Iqbal Open University

Islamabad, Punjab Province, 45710, Pakistan

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Khalid Mahmood, MPhill

    Akuwat

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blinded trial, Intervention and placebo given
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled placebo trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nutritionist

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 19, 2018

Study Start

March 23, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)