EFFECT OF SEED BASED NUTRITIONAL SUPPLEMENT ON THE SYMPTOMS OF POLYCYSTIC OVARIAN SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE (20- 45 YEARS)

Phase 3

Recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2021/09/036850
• Lead Sponsor: Jyothi S Krishnan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-27
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
estimate the Impact of the formulated micronutrient rich powdered Formula on	12 weeks
Women of Reproductive age having Polycystic Ovarian Syndrome in terms of the	12 weeks
following: hormonal levels, metabolic features, clinical features, anthropometric measures	12 weeks

Secondary Outcome Measures

Name	Time	Method
Study the etiological factors contributing to PCOS, Assessment of mental Health status, Assessment of physical activity level, Assessment of dietary pattern	3 months

Trial Locations

Locations (1)

Department of Nutrition and Dietetics; 🇮🇳 Pathanamthitta, KERALA, India

Department of Nutrition and Dietetics

🇮🇳Pathanamthitta, KERALA, India

Jyothi S Krishnan

Principal investigator

04692742800

jokrishna1983@gmail.com