CTRI/2025/04/084192 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On:
28/03/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Behavioral Other (Specify) [Epidemiological]
Study Design
Other
Public Title of Study
How a Millet Diet and Yoga Affect Weight, Health, and Well-Being in Women with PCOS
Scientific Title of Study
Effect of millet-based diet and yoga intervention on body
composition, metabolic profiles and Health-Related quality
of life in women with polycystic ovarian syndrome.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Daksha Kumari
Designation
Assistant Professor
Affiliation
Manipal College of Health Professions
Address
Department of Clinical Nutrition and Dietetics,4th Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi KARNATAKA 576104 India
Phone
7406109925
Fax
Email
dakshakumari@gmail.com
Details of Contact Person Scientific Query
Name
Daksha Kumari
Designation
Assistant Professor
Affiliation
Manipal College of Health Professions
Address
Department of Clinical Nutrition and Dietetics,4th Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi KARNATAKA 576104 India
Phone
7406109925
Fax
Email
dakshakumari@gmail.com
Details of Contact Person Public Query
Name
Daksha Kumari
Designation
Assistant Professor
Affiliation
Manipal College of Health Professions
Address
Department of Clinical Nutrition and Dietetics,4th floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Millet based diet and yoga
Participants will receive complete study information, and informed consent will be obtained from those meeting inclusion/exclusion criteria. A baseline assessment will collect demographic details, including age, residence, family structure, marital status, education, employment, and income.
Anthropometric measurements (height, weight, waist and hip circumference, MUAC, calf circumference) will be taken using standardized equipment. Biochemical assessments, recorded from computer-generated lab reports, will measure fasting blood sugar (Hexokinase), HbA1c (HPLC), HOMA-IR (ECLIA), total cholesterol (CE-CHOD-POD), LDL (enzymatic), HDL (direct homogeneous), triglycerides (GPO), and testosterone (ECLIA). Dietary intake will be assessed through a food frequency questionnaire and 24-hour recall, analyzed using DietCal 13.0. Physical activity will be evaluated with GPAQ, and quality of life using PCOSQoL-47 and PCOSQoL-42. Body composition, including visceral and subcutaneous fat and muscle mass, will be measured with a body fat analyzer.
The intervention group will receive 20-minute counseling sessions and a personalized millet-based breakfast plan. Participants will receive recipe folders and cooking instructions. Sensory evaluations with a 9-point Hedonic scale will assess acceptability. Recipes will incorporate 60–100% millet (ragi, pearl millet, kodo millet, foxtail millet, little millet) and provide 300 kcal, 10g protein, 50g carbohydrates, 10g fat, and 10g fiber. Participants will measure raw ingredient weights using measuring cups provided to ensure accuracy. Daily adherence will be monitored through breakfast snapshots sent via phone.
In addition to the dietary plan, participants will practice yoga (asanas and pranayama) for 40 minutes, six days a week for 180 days. A MAHE, Manipal yoga instructor will provide individual training for four days, followed by online sessions twice a week for 90 days, with home practice on other days. Participants will then continue home practice, recording progress in a diary. A booklet and video guide will be provided.
Follow-up assessments will be conducted via phone calls on days 15, 30, and 60, recording dietary intake and reinforcing adherence to diet and yoga. On the 90th day, participants will visit the hospital for outcome-based assessments, including anthropometric and biochemical measurements, dietary analysis (24-hour recall, food frequency, DietCal 13.0), physical activity (GPAQ), body fat analysis, and quality of life evaluation (PCOSQoL-47, PCOSQoL-42). On day 135, a phone call will reinforce diet and yoga adherence.
On the 180th day, participants will return for compliance checks, repeating assessments from day 90. Adherence to diet and yoga will be evaluated, and participants who fail to follow the intervention for two consecutive weeks will be considered dropouts.
Comparator Agent
Standard care plan
Participants will receive complete study information, and informed consent will be obtained from those meeting inclusion/exclusion criteria. Baseline assessments will collect demographic details, including age, residence, family structure, marital status, education, employment, and income.
Anthropometric measurements (height, weight, waist and hip circumference, MUAC, calf circumference) will be recorded in the OPD. Biochemical parameters, recorded from computer-generated lab reports, will include fasting blood sugar (Hexokinase), HbA1c (HPLC), HOMA-IR (ECLIA), total cholesterol (CE-CHOD-POD), LDL (enzymatic), HDL (direct homogeneous), triglycerides (GPO), and testosterone (ECLIA). Dietary intake will be assessed through a food frequency questionnaire and 24-hour recall, analyzed using DietCal 13.0. Physical activity will be evaluated with GPAQ, and quality of life using PCOSQoL-47 and PCOSQoL-42. Body composition, including visceral and subcutaneous fat and muscle mass, will be measured with a body fat analyzer.
The control group will receive a standard diet care plan tailored to their medical needs and guidance on regular physical activity during their initial hospital visit. Until the 90th day, there will be no follow-up contact.
On the 90th day, participants will return for an outcome-based assessment, including anthropometric and biochemical measurements, dietary analysis (24-hour recall, food frequency, DietCal 13.0), physical activity assessment (GPAQ), body fat analysis, and quality of life evaluation (PCOSQoL-47, PCOSQoL-42).
On the 180th day, participants will return for compliance checks, repeating the assessments from day 90 to evaluate adherence to the study protocol.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
30.00 Year(s)
Gender
Female
Details
Ready to follow millet-based diet and yoga as prescribed if randomly allocated
to the intervention arm.
ExclusionCriteria
Details
PCOS Women with millet-related contraindications, like chronic kidney
disease, and GI disorders.
Patients with Thyroid disorders.
Patients who are on steroids.
Patients who are on psychiatry medications.
Patients with medication predisposing to metabolic syndrome.
Patients who are already practicing Yoga, Meditation.
Patients who are already consuming millets regularly in their diet.
Patients undergoing infertility treatment.
Patients with diabetes.
Patients with any other chronic systemic illness.
Patients with disorders of spine.
Patients with a history of millet allergy
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
The main focus of the study is the effect of a millet-based diet and yoga intervention on body composition, metabolic profiles, and health-related quality of life (HRQoL) in women with polycystic ovarian syndrome (PCOS)
Assessments will be conducted at baseline, 90 days, and 180 days to evaluate changes in the primary outcome measures.
Secondary Outcome
Outcome
TimePoints
To assess the intake of millets and knowledge, attitude, and practice (KAP) of millets among PCOS women.
To assess the knowledge, attitude, and practice (KAP) of yoga among PCOS women To identify the facilitators and barriers to lifestyle modification in women with
PCOS.
6 months
Target Sample Size
Total Sample Size="92" Sample Size from India="92" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
10/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This randomized controlled trial examines the impact of a millet based diet and yoga intervention on women aged 18 to 30 years with polycystic ovarian syndrome (PCOS) attending the endocrinology outpatient department at Kasturba Hospital, Manipal. The study aims to assess improvements in metabolic profiles, body composition, symptom management, and health related quality of life through the integration of millet based dietary intake and regular yoga practice.