| CTRI Number |
CTRI/2024/02/062374 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on impact of multi seed bar and nutrition education on health and performance of sports persons. |
|
Scientific Title of Study
|
Effect of nutritional intervention on selected muscle markers, body composition variables, physical fitness parameters and micronutrient indices among athletes in Chennai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J Sai laavanya |
| Designation |
Full time Ph.D Research Scholar |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur |
| Address |
Department of Clinical Nutrition and Dietetics,
SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur
No.11, Palaniandavar street,
Radhanagar,
Chromepet,
Chennai - 600044.
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
09500065402 |
| Fax |
|
| Email |
laavanyasai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.K.Silambu selvi |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur |
| Address |
Department of Clinical Nutrition and Dietetics,
SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09488603336 |
| Fax |
|
| Email |
silambuk1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
J Sai laavanya |
| Designation |
Full time Ph.D Research Scholar |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur |
| Address |
Department of Clinical Nutrition and Dietetics,
SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur
No.11, Palaniandavar street,
Radhanagar,
Chromepet,
Chennai - 600044.
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
09500065402 |
| Fax |
|
| Email |
laavanyasai@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur |
|
|
Primary Sponsor
|
| Name |
Sai laavanya J |
| Address |
Department of Clinical Nutrition and Dietetics, SRM Medical College Hospital and Research Centre, SRMIST, Kattankulathur-603203. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrKSilambu selvi |
SRM Medical College Hospital and Research Centre, SRMIST |
Department of Clinical Nutrition and Dietetics,
Sixth floor, SRM Medical College Hospital and Research Centre, SRMIST, SRM Nagar
Kattankulathur
603203.
Kancheepuram
TAMIL NADU |
9488603336
silambuk1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Nutrition education for three months |
| Intervention |
Experimental group |
Supplementation of 50 g of multi seed bar for 5 days per week for three months along with nutritional education |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Female athletes who are active in sports for 3-4 days per weeks and willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Male athletes
Female Athletes less than 17 years and greater than 25 years
Female Athletes with major health complications and those consuming medications or supplements
Female Athletes who are pregnant or lactating
Female Athletes not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To enable athletes to consume seeds and improve their sports performance |
0 days to 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve body composition, muscle markers, micronutrient indices and physical fitness parameters of athletes. |
0 days to 90 days |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 3 |
|
Date of First Enrollment (India)
|
12/02/2024 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This study is a randomized parallel group active trial
involving female athletes of 17-25 years of age. The experimental group is
supplemented with a multi seed bar for 5 days per week for a period of 3 months
along with nutrition education and the control group is provided with nutrition
education alone. The body composition, physical fitness parameters, selected muscle
markers and micronutrient indices are assessed before and after the intervention
to analyze the effect of nutritional intervention on the female athletes. |