IMPACT OF NUTRITION INTERVENTION ON THE SYMPTOMS OF POLYCYSTIC OVARIAN SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE (20- 45 YEARS)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- estimate the Impact of the formulated micronutrient rich powdered Formula on
Study Overview
Brief Summary
Conduct of the study
Phase 1:
ï‚· Assessment of nutritional status using Anthropometric, Biochemical, Clinical and Diet history.
ï‚· Anthropometrics measurements Height, Weight, BMI, Waist Circumference, Hip circumference, Waist Hip Ratio (ICMR, 2010).
ï‚· Analysis of Biochemical Parameters .The following biochemical parameters are evaluated:
o Total serum testosterone
o Haemoglobin ( Hb)
o Lipid Profile
o Random Blood sugar
ï‚· Assessment of Clinical Parameters
o Hirsutism, Acne, Acanthosis Nigricans, Greasy skin, Alopecia
ï‚· Assessment of food and Nutrient Intake using Food diary ,3 day food record
Phase 2: Identification of Micronutrient rich food items and development of nutritional supplement and Evaluation of the supplement suitable for PCOS
| Ingredients Amount(gm) | |
| Pearl Millet 15 | |
| Finger Millet 10 | |
| Flax seeds 20 | |
| Pumpkin Seeds 20 | |
| Sesame seeds 15 | |
| Sunflower seeds 15 | |
| Brown Sugar 5 | |
| Total 100 |
Phase 3: Provide nutrition intervention using Standard Dietary intervention alone and with formulated supplement
Study Design:
Randomized Controlled Trial where patients will be assigned to the two groups described below using fish bowl technique
Group 1 – Nutrition Education
Group 2- Nutrition Education +Supplement
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All women of reproductive age group (20-45 years), Screening for PCOS is done by using a validated Clinical Tool, Not taking any medication.
Exclusion Criteria
- •Age less than 20 years and greater than 45 years, Other comorbidities, Concurrent treatment.
Outcomes
Primary Outcomes
estimate the Impact of the formulated micronutrient rich powdered Formula on
Time Frame: 12 weeks
Women of Reproductive age having Polycystic Ovarian Syndrome in terms of the
Time Frame: 12 weeks
following: hormonal levels, metabolic features, clinical features, anthropometric measures
Time Frame: 12 weeks
Secondary Outcomes
- Study the etiological factors contributing to PCOS, Assessment of mental Health status, Assessment of physical activity level, Assessment of dietary pattern(3 months)