| CTRI Number |
CTRI/2024/11/077268 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Development of Diet eduction handout for women with ovarian cyst. |
|
Scientific Title of Study
|
Development and validation of low carbohydrate high fats adequate protein and liquid diet with time restricted meal (CHEESE Diet) for women with polycystic ovarian syndrome (PCOS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hijam Tararani |
| Designation |
Junior resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
NIH-A block room no 1201, KMC Manipal, Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8310824522 |
| Fax |
|
| Email |
dr.hijamtararani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhiren Punja |
| Designation |
Professor and Head Department of Physiology |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Department of Physiology, KMC Manipal, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845558131 |
| Fax |
|
| Email |
dhiren.punja@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Hijam Tararani |
| Designation |
Junior resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
NIH-A block room no 1201, KMC Manipal, Madhav Nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8310824522 |
| Fax |
|
| Email |
dr.hijamtararani@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHE Post graduate research Grant, Manipal,Madhav Nagar, Eshwar Nagar, 576104 |
|
|
Primary Sponsor
|
| Name |
MAHE Post graduate research Grant Self funding Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal, Madhav Nagar, 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| HijamTararani |
1.Kasturba Medical College. 2. Manipal College of Health Professions,Manipal,Madhav Nagar, 576104 |
Department of Reproductive Medicine and Surgery,Room no 1. Department of Physiology, KMC Manipal
Nutrition and Dietetics, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA |
8310824522
dr.hijamtararani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Development and content validation of diet education handout(low carbohydrate high Fat,adequate protien with liquid diet)(phase1), Feasibility intervention study (phase2) |
The development and content validation of the diet education handout will be for 2months. The diet therapy aims to improve symptoms of PCOS, potentially benefiting participants by improving menstrual cycles, promoting weight loss, and enhancing lipid profiles and anti-Müllerian hormone levels. The intervention is not anticipated to pose any significant additional risks and may enhance overall well-being. The intervention will be for 3 months and another 3 months of follow up (Total 6months) |
| Comparator Agent |
Development and content validation of diet education handout(phase1), Feasibility intervention study(phase2) |
Control group will undergo investigation as the intervention group, but will not follow the diet therapy. After a duration of 8weeks and 12 weeks they will be followed up with the repeat of investigations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Women In their reproductive age diagnosed
with PCOS.
2 Residing 50km near the KMC hospital
3 First visit for infertility test
4 BMI greater than 25 kg/m sq
5 Low and Moderate category of
International Physical Activity (IPAQ)
questionnaire. (Total physical activity of
at least 600 MET- minutes/week)
|
|
| ExclusionCriteria |
| Details |
1 Below 18 years or above 40 years of age
2 Pregnant and lactating women
3 Diabetes Mellitus, on medication
4 Neurological disorders
5 Women who become pregnant during the
intervention
• Inflammatory diseases
• Women on medication affecting study
outcomes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase1- Development of diet hand out for PCOS women
Phase2- Measurements of Body Mass Index(BMI), Body Fat mass, waist hip ratio, lipid profile, HbA1c,AMH |
Phase1- Development of diet hand out for PCOS women
Phase2- Measurements of Body Mass Index(BMI), Body Fat mass, waist hip ratio, lipid profile, HbA1c,AMH on 1st day, then on 4th week and then on 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI kg m sq, Lipid profile mg %, waist hip ratio cm/ inches, body fat mass kg/m sq, AMH ng/mL, feasibility test and accessibility test |
6months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="2"
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
|
Phase1- Qualitative co-design phase Objective- To develop and validate a Diet education Handout (DEH) for women with PCOS, termed as the CHEESE Diet, utilising a co-design approach Sample size- 12(6 vegetarian and 6 non vegetarian) Procedure-A FGD will be conducted at the Reproductive Medicine and Surgery Department, KMC Manipal. Facilitators and a scribe will introduce themselves to participants, outlining the study’s aims, discussion rules, and confidentiality agreements. Participants will be informed about audio recording for data analysis and their role in the study. The facilitator will introduce the CHEESE DEH (Dietary Education Handout) development process, followed by administering food frequency and 24-hour diet recall questionnaires. Participants will complete two 24-hour diet recalls via telephone, spaced three days apart, following this discussion. Based on insights from the FGD and 24-hour diet recalls, an initial draft of the DEH will be prepared. Content experts will receive a content validity questionnaire to score and provide feedback. The DEH will undergo revisions until it meets standard validation scores, ensuring content validity. Phase2- Feasibility Intervention Stage Objective-To test the feasibility of the CHEESE DEH and evaluate Anthropometric measurements, lipid profile, FBS, HbA1c, and anti mullerian hormone in women with PCOS following the CHEESE diet. Sample size- The total no of participants: 30 (including intervention and control group having 15 participants each) Procedure-After receiving written informed consent and gathering demographic information, participants will be enrolled in the study. Each participant will receive a complete explanation of the study protocol, a Patient Information sheet (PIS) and a consent form will be obtained. Various health parameters will be assessed during the study, including Body Mass Index (BMI), Waist Circumference (WC), body fat percentage, lean mass, lipid profile, anti-Müllerian hormone and HbA1c. BMI will be calculated using weight (in kilograms) divided by the square of height (in meters). WC will be measured using a measuring tape. Body fat will be measured using the Body stat 1500 MDD device. Blood samples will be collected after an overnight fast during the first visit. Participants will also complete a Food Frequency Questionnaire (FFQ). Additionally, a 24-hour diet recall will be conducted to record participants’ food intake over the previous day during the first visit. Participants will be asked to complete two more 24-hour diet recalls at home within the next three months, one on a weekday and one on a weekend day. The International Physical Activity Questionnaire (IPAQ) will assess participants’ physical activity levels over the past week during the first visit. After completing the baseline assessment, participants will be assigned to the intervention and control group. Participants enrolled in the CHEESE Diet intervention will be provided with detailed Dietary Education Handouts (DEH) to follow at home for 12 weeks. Exercise can be one of the confounding variables therefore participants will be asked not to start any new exercise regimen and if the patient is following any exercise prior to the study should be kept constant throughout the study. Participants will be requested to share pictures of their daily food intake via WhatsApp. Adherence to the intervention will be monitored through bi-monthly telephone calls. Motivational counseling will be provided via phone as needed. Participants have the option to withdraw from the study at any time. Immediate post intervention follow-up: Participants will undergo follow-up assessments after 3 months to measure the Body Mass Index (BMI), Waist Circumference (WC), body fat percentage, lean mass, lipid profile, anti-Mullerian hormone, fasting blood glucose and HbA1c. These assessments and follow-ups are part of the standard study protocol. Participants will complete the food frequency questionnaire and 24-hour diet recall. Participants will be encouraged to continue the same diet for an additional 3 months. However, no adherence measures in the form of telephonic calls or WhatsApp interaction will be done during this time. Participants will be instructed not to change their physical activity levels during this time. Short term follow-up: At the end of 6 months, Participants will undergo follow-up assessments to measure the Body Mass Index (BMI), Waist Circumference (WC), body fat percentage, lean mass, lipid profile, anti-Müllerian hormone and HbA1c. Participants will complete the food frequency questionnaire and 24-hour diet recall. Feasibility and acceptability assessment will be done for 3months.
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