| CTRI Number |
CTRI/2024/06/069562 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pumpkin seed on blood sugar, fat and hereditary status of Metabolic Syndrome |
|
Scientific Title of Study
|
Effect of pumpkin seed on anthropometric, biochemical and genetic marker of Metabolic 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 |
Dr Dileep Kumar Verma |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Physiology, King Georges Medical University
Shah Mina Road, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9415469113 |
| Fax |
|
| Email |
dileepvermaindia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dileep Kumar Verma |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Physiology, King Georges Medical University
Shah Mina Road, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9415469113 |
| Fax |
|
| Email |
dileepvermaindia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dileep Kumar Verma |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Physiology, King Georges Medical University, Shah Mina Road, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9415469113 |
| Fax |
|
| Email |
dileepvermaindia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiology, King Georges Medical University, Shah Mina Rd, Chowk,
Lucknow, Uttar Pradesh 226003
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan,
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Dileep Kumar Verma |
King Georges Medical University |
Department of
Physiology, King
Georges Medical
University, Shah Mina
Road, Chowk Lucknow UTTAR PRADESH |
9415469113
dileepvermaindia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King Gorges Medical University, Lucknow, UP, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Pumpkin seed
powder |
30 gm/day (15 gm before half an hour of breakfast
and 15 gm before half an hour of dinner) from
baseline till 3 months |
| Comparator Agent |
Control(No
intervention) |
Without pumpkin seed supplementation from
baseline till 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Metabolic syndrome patients aged between 18-60 years
2. Metabolic Syndrome with three or more of the following five criteria is met:
hyperglycemia, raised blood pressure, elevated triglyceride levels, low high-density
lipoprotein cholesterol levels, and central obesity [NCEP (ATP III)].
3. Patient of either sex i.e., both male and female.
4. Patient willing to consent in writing |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in the study
2. Aged less than 18 and more than 60years
3. Pregnant, nursing, or planning for pregnancy
4. Active medical condition- a known allergy or intolerance
5. Patient having any medical or surgical illness requiring priority management
6. Patient with other endocrinal diseases
7. Patient with Frank hepatorenal complication
8. Patient with chronic illness, congenital disorder, neurological and psychiatric disorder.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Manage reduction of Fasting blood glucose and Post prandial glucose
2. Decrease HbA1c
|
Glycaemic profile will be measured:
First is at Baseline (at the time of patient
enrollment)
Second is Follow-up (after 12 weeks {3
months} of patient enrollment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. Decrease Triglycerides, low-density
lipoproteins Cholesterol, Total
Cholesterol, Increase HDL
4. Decrease IL-6 (Interleukin-6), TNFα
5. Expression enhancement of Adiponectin levels & its gene expression due to alternative
therapies (pumpkin seed powder) |
Anthropometric Measurements, Clinical
parameters, Biochemical Parameters, genetic marker will be
measured:
First is at Baseline (at the time of patient
enrollment)
Second is Follow-up (after 12 weeks {3
months} of patient enrollment)
|
|
|
Target Sample Size
|
Total Sample Size="648" Sample Size from India="648"
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)
|
15/07/2024 |
| 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="3" Months="0" 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
|
The metabolic syndrome is a cluster of risk factors that
identifies a population with increased risk for developing type T2DM and
cardiovascular disease (CVD). The prevalence of metabolic syndrome in urban
population of India was 32%. The Adult Treatment Panel III (ATPIII) criteria of
the National Cholesterol and Education Program (NCEP The diagnostic criteria
for metabolic syndrome are the presence of any three of the following five
components is diagnostic for the metabolic syndrome: Central obesity, elevated
blood pressure, raised fasting glucose, raised levels of triglycerides and low
levels of high-density lipoprotein cholesterol. Although, the most common
treatment is medications but in recent time, use of nutritional methods and
medicinal plants are also increasing and gaining importance due to their high
margin of safety. However, some of them have been studied scientifically and pumpkin
seed is one of them. Thus, the objective of the study was to assess the effect
of pumpkin seeds on glycaemic profile, lipid profile, anthropometric
measurements and adiponectin level and its gene expression in metabolic
syndrome patients. The study patients will be recruited from OPD of Department
of Medicine, with collaboration Department of Physiology, King Georges Medical
University, Lucknow. Enrollment of patients will be done according to inclusion
criteria. Then baseline assessments will be done of anthropometric measurements
i.e., BMI, WHR, biochemical parameters like CBC, FBS, PPBS, HbA1c and TG, TC,
LDL, HDL, IL-6 (Interleukin-6), Tumor necrosis factor- alpha (TNF-α), Adiponectin
level and its Gene Expression and clinical parameters including BP and Heart
rate. Then supplementation of 30 gm pumpkin seed per day i.e., 15 gm before
half an hour of breakfast and 15 gm before half an hour of dinner will be given
to the case group patients for 3 months and no intervention in the control
group will be given. Compliance of daily consumption of pumpkin seeds would be
monitored in the case group. All case group patients will be requested to
return their supplement packaging every month. The pumpkin seeds will be
provided to the patients every month for a duration of 3 months. The follow up
assessment of the patients will be done after 3 months of pumpkin seed
supplementation. The baseline and follow up assessments, data will be compiled,
entered in Microsoft Excel spreadsheet for further data statistical analysis. |