| CTRI Number |
CTRI/2024/09/073262 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Lactovegetarian Diet and Intermittent Fasting] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of lactovegetarian diet and intermittent Fasting on improving glycemic, lipemic profile and Quality of Life in Diabetic Women |
|
Scientific Title of Study
|
Effect of the Lactovegetarian Diet and Intermittent Fasting on Metabolic Parameters and Quality of Life Among Type 2 Diabetic Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu Mahajan |
| Designation |
JRF, PhD Scholar |
| Affiliation |
Symbiosis International (Deemed) Univeristy |
| Address |
Faculty Block, Symbiosis School of Culinary Arts and Nutritional Sciences, Symbiosis International University, Ghram Lavale, Mulshi
Pune
MAHARASHTRA
412115
India |
| Phone |
08171889888 |
| Fax |
|
| Email |
anumahajan835@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arti Muley |
| Designation |
Assistant Professor |
| Affiliation |
Symbiosis International (Deemed) University |
| Address |
Faculty Block, Symbiosis School of Culinary Arts and Nutritional Sciences, Symbiosis International University, Ghram Lavale, Mulshi
Pune
MAHARASHTRA
412115
India |
| Phone |
7219515313 |
| Fax |
|
| Email |
asmuley@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arti Muley |
| Designation |
Assistant Professor |
| Affiliation |
Symbiosis International (Deemed) University |
| Address |
Faculty Block, Symbiosis School of Culinary Arts and Nutritional Sciences, Symbiosis International University, Ghram Lavale, Mulshi
Pune
MAHARASHTRA
412115
India |
| Phone |
7219515313 |
| Fax |
|
| Email |
asmuley@gmail.com |
|
|
Source of Monetary or Material Support
|
| Symbiosis University Hospital & Research Center, Dnyan
Marg, Mulshi Road, Lavale, Taluka Mulshi, Pune 412115 |
|
|
Primary Sponsor
|
| Name |
Anu Mahajan |
| Address |
Symbiosis International (Deemed University) Ghram Lavale, Taluka Mulshi, Pune, 412115 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali Deshmukh |
SPHERE (Society for prevention, healthcare, education and research) |
Deshmukh Clinic and Research Centre, 2nd floor pinnacle prestige above cosmos bank, Lokmanya Bal Gangadhar Tilak Rd, near survankur hotel, Pune, Maharashtra 411030
Pune
MAHARASHTRA |
9850811450
wow.dcrc@gmail.com |
| Dr Arti Muley |
SUHRC (Symbiosis University Hospital and Research Centre) |
Dnyan Marg, Mulshi Rd, Lavale, Maharashtra 412115
Pune
MAHARASHTRA |
7219515313
asmuley@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee(BHR)-SIU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactovegetarian Diet & Intermittent Fasting |
Plant based diet and diary products for a period of 3 months |
| Comparator Agent |
Standard Diabetic Diet |
Diabetic Diet for 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
The study includes the women population with or without hypertension with a minimum of 1 year of Diabetes. The included participants must have an age between 25-60 years with HbA1c values 6.5-9.0. Subjects taking any oral hypoglycemic agents are considered for the study. |
|
| ExclusionCriteria |
| Details |
The study excludes Males and those who do not wish to disclose gender are excluded from the study. Pregnant, Lactating women or with Gestational Diabetes Mellitus(GDM) are not considered for the study. Any women with co-morbidities like PCOS/PCOD, thyroid, Cancer, HIV, CVD are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fasting blood sugar, HbA1c |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight, BMI, lipid profile, Quality of life |
24 week |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study " Effect of Lactovegetarian Diet and Intermittent Fasting on Metabolic Parameters and Quality of Life Among Type 2 Diabetic Women- A Randomized Prospective Controlled Study" aims to study the impact of Lactovegetarian Diet(combination of Plant-based and Diary products) and Intermittent Fasting (Time and Calorie Restricted) on Type 2 Diabetic Women. Diabetes is a chronic disease and increases the risk of complications associated with it. It has been that Dietary management plays an important role in controlling blood sugar levels and reducing the risk of complications. The study is done at two major centers in Pune, India. These include SUHRC (Symbiosis University Hospital & Research Center) and SPHERE (Society of Prevention, Healthcare, Education and Research). The participants are randomized into two groups: One following the Lactovegetarian Diet and Another following the Standard Diabetic Diet as advised by ICMR. The intervention is given for 3 months, and regular follow-up will be conducted.
The study’s primary objective is to investigate the effect of the Lactovegetarian diet and Intermittent fasting on improving the glycemic and lipemic profile of Diabetic Women. The study also focuses on investigating the effect of intervention in the reduction of weight, BMI, and Blood pressure. It also sees the adherence of the participants to the intervention and improvement in their Quality of Life before and after the intervention
|