| CTRI Number |
CTRI/2022/11/047570 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on HDL (high density lipoproteins) and LDL (low density lipoproteins) of selected college going students, Manipal. |
|
Scientific Title of Study
|
Prevalence of dyslipidemia in selected college going students, Manipal : A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apeksha Mohan |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal |
| Address |
Mandavi Emerald Eshwar Nagar e tower E- 703
Welcomgroup Graduate School of Hotel Administration, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7619484513 |
| Fax |
|
| Email |
apeksha.mohandas@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namratha Pai K |
| Designation |
Professor |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal |
| Address |
Welcomgroup Graduate School of Hotel Administration, Manipal - 576104
Welcomgroup Graduate School of Hotel Administration, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9738364472 |
| Fax |
|
| Email |
namratha.paik@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha Pai K |
| Designation |
Professor |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, Manipal |
| Address |
Welcomgroup Graduate School of Hotel Administration, Manipal - 576104
Welcomgroup Graduate School of Hotel Administration, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9738364472 |
| Fax |
|
| Email |
namratha.paik@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Apeksha Mohan |
| Address |
Welcomgroup Graduate School of Hotel Administration, Manipal - 576104 |
| Type of Sponsor |
Other [self sponsor ] |
|
|
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 |
| Apeksha Mohan |
WGSHA, Manipal |
[welcomgroup Graduate School Of Hotel Administration,MAHE,udupi,Manipal]
Bachelor of Hotel Management (I,II, III year) classroom 300
MSc Dietetics and Applied Nutrition - classroom 203
Udupi
KARNATAKA |
7619484513
apeksha.mohandas@learner.manipal.edu |
|
|
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 |
| Healthy Human Volunteers |
Stable health |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
This study includes young adults aging from 18-25 years of both gender groups, male
and female. Students who have given consent for participation. |
|
| ExclusionCriteria |
| Details |
It excludes adults above 25 years of age and below 18 years of age. Pregnant and
lactating women, Students already having a complication of CVD are also to be
excluded.
Students with any disability are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of dyslipidemia
Altered lipid profile
Altered anthropometry
Inappropriate Lifestyle and eating habits |
3- 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalence of dyslipidemia
Altered lipid profile
Altered anthropometry
Inappropriate Lifestyle and eating habits |
3-6 months
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/11/2022 |
| 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="1"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is a huge global health issue. Overweight and obesity have become much more common in recent decades, not just in high-income countries, but also in middle- and low- income countries. Visceral or abdominal obesity is a strong predictor of cardiovascular risk. Increased body mass index has been demonstrated to be a weaker predictor of cardiovascular risk than abdominal obesity.
The students should not eat any junk food two days prior to the lipid profile test. Blood samples will be taken to determine the lipid levels, a few questions about their lifestyle choices and habits using a Google Forms questionnaire will be given, and according to their consent the anthropometric measures will be taken. Their abdominal fat will be noted using the Skinfold caliper, and their waist and hip circumferences will be measured simultaneously using the measuring tape. The relationship between their occupation, lipid levels, and upper abdominal obesity will be recorded. |