| CTRI Number |
CTRI/2024/12/077943 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How eating pearl millet affects fat levels and body weight |
|
Scientific Title of Study
|
Study the impact of pearl millet consumption on lipid profile and body weight |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Dinesh V |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences NEW DELHI |
| Address |
Department of Medicine
All India Institute of Medical Sciences NEW DELHI
India
South
DELHI
110029
India |
| Phone |
9344187405 |
| Fax |
|
| Email |
dineshvd231998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranveer Singh Jadon |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Medicine AIIMS NEW DELHI
New Delhi
110029
India
South
DELHI
110029
India |
| Phone |
9540951048 |
| Fax |
|
| Email |
rsjadonaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranveer Singh Jadon |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Medicine AIIMS NEW DELHI
New Delhi
110029
India
South
DELHI
110029
India |
| Phone |
9540951048 |
| Fax |
|
| Email |
rsjadonaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical science, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, INDIA, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Dinesh V |
| Address |
Department of Medicine
AIIMS NEW DELHI
110029
India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Dr DINESH V |
AIIMS NEW DELHI |
Department of medicine
New RAK OPD, A and B wing 2nd floor
Ansari nagar
AIIMS NEW DELHI
New Delhi
South
DELHI |
9344187405
dineshvd231998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pearl millet-based diet along with standard of care |
Pearl millet based diet (90-100gm per day) replacing one of the three meal (33% of total cereal intake) in any preparation like roti, dosa, cheela, porridge, upma, pancakes, bread etc. Exercise minimum 30 minutes per day for 5 or more days in a week/150 minutes per week.
Low calorie,low fat and carbohydrate, high fibre diet recommended.
Custom made lifestyle modification and dietary advise will be given by Nutritionist. |
| Comparator Agent |
Standard of care |
Exercise minimum 30 minutes per day for 5 or more days in a week/150 minutes per week. Low calorie,low fat and carbohydrate, high fibre diet recommended. Custom made lifestyle modification and dietary advise will be given by Nutritionist. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Bmi more than or equal to 25kg/m2
Dyslipidemia-Any one of the following without indication of lipid lowering drug
Triglyceride more than or equal to 150mg/dl
HDL cholesterol less than 40 in men, less than 50 in women
Total Cholesterol more than or equal to 200mg/dl
LDL more than or equal to 100mg/dl
Individuals not planning for nay pharmacotherapy and bariatric surgery for obesity in next 3 month |
|
| ExclusionCriteria |
| Details |
Type 2 Diabetes Mellitus (FBS more than or equal to 126mg/dL,PPBS more than or equal to 200mg/dL ,HbA1c more than or equal to 6.5%)
On medication for Obesity/Dyslipidaemia
Already on Millet based diet plan in past 3 months
On medication which affect the lipid profile and body weight (statins,ART,antiepileptics/psychotics,OHA,beta blockers,VitA analogues.)
Chronic heavy alcohol user(consuming 40-80g/day for men,20-40g/day for women) and patient with known psychiatric illnesses(eating disorder)
Acute or chronic heart failure, CKD (Stage 3 or more), CLD (Child class B or C),
Acute and chronic infections eg HIV, tuberculosis, chronic Hep C and Hep B
Known active malignancies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of Pearl Millet consumption on body weight and lipid profile among Obese individuals with Dyslipidemia |
Shall be assessed at baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of pearl millet consumption on glycemic parameters, including fasting and postprandial blood glucose and HbA1c levels, as well as on insulin resistance (HOMA-IR and HOMA-B) in obese patients |
Shall be assessed at baseline and after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/12/2024 |
| 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="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It
is a prospective,open label, randomised parallel group ,active controlled trial
to study the impact of Pearl
Millet consumption on body weight and lipid profile among Obese individuals
with Dyslipidemia. Patients aged ≥ 18years, BMI ≥ 25kg/m2
with dyslipidemia is included in the study after exclusion criteria.
After that, patients will be randomized using computer generated block method
into 2 groups-intervention and control. Objective is to study the impact of
Pearl Millet consumption on body weight and lipid profile among Obese
individuals with Dyslipidemia after 12 weeks of intervention. Secondary
objective is to assess the effect of pearl millet consumption on glycemic
parameters, including fasting and postprandial blood glucose and HbA1c levels,
as well as on insulin resistance (HOMA-IR and HOMA-B) in obese patients.
Intervention group will be introduced with pearl millet based diet along with
standard of care and control group with standard of care. Patients will be assessed
with investigations at baseline and after 12 weeks and follow up will be done
through phone call and physically. Statistical analysis will be done to compare
the results in both groups. |