Home » Trials » SLCTR/2024/013
Investigating the effects of a 16-week evidence-based, culturally accepted, personalized sports nutrition intervention on the sports nutrition knowledge and nutritional status of elite athletes in Sri Lanka
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SLCTR Registration Number
SLCTR/2024/013
Date of Registration
The date of last modification
Apr 19, 2024
Scientific Title of Trial
Investigating the effects of a 16-week evidence-based, culturally accepted, personalized sports nutrition intervention on the sports nutrition knowledge and nutritional status of elite athletes in Sri Lanka
Public Title of Trial
Impact of a 16-week personalized nutrition education program on elite athletes in Sri Lanka on improving sports nutrition knowledge and nutritional status’
Disease or Health Condition(s) Studied
Sports Nutrition Knowledge (SNK)
Scientific Acronym
SPORT-NUT
Public Acronym
Sports_nutri_knowledge
Brief title
None
Universal Trial Number
U1111-1304-8890
Any other number(s) assigned to the trial and issuing authority
2023/EC/71:University of Peradeniya
What is the research question being addressed?
Does a 16-week evidence-based, culturally accepted, personalized sports nutrition intervention enhance sports nutrition knowledge and improve nutritional status compared to no nutritional intervention in elite athletes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
• Strict protocols will be implemented to prevent knowledge sharing between groups. • The intervention group will receive personalized nutrition education individually by the PI which may not be relevant to fellow athletics. • Participants will be instructed not to discuss study-related information with others during the recruitment produces. • The competitive and passionate nature of the participants reduces the likelihood of contamination. • Reassurance will be provided to the control group that they will have access to the personalized nutrition education program after the intervention by the PI.
As part of the intervention, we will not provide any vitamins and nutritional supplementation. Only advices of taking them.
Inclusion criteria
Exclusion criteria
-Chronic illnesses and current injuries -Paralympic athletes -Those who are on an already prescribed diet -Those who are largely dependent on outside food -Those who have changed their sport events in the last year -Those who are addicted to alcohol and smoking -Pregnant and lactating athletes
Primary outcome(s)
|
1.
The number of participants who achieved a 10% increase in mean sports nutrition knowledge scores at the end of the 16th week in the intervention group compared to the control group. Sports nutrition knowledge will be assessed using a validated inhouse country-specific sports nutrition knowledge questionnaire. |
[ Before and at the end of the 16th week following the intervention ] |
Secondary outcome(s)
|
1.
Nutrition status collected using anthropometric, biochemical, and body composition parameters in the intervention group and control group |
[ Before the interventions, at the end of the 4th week, the 8th week, and the 16th week following the intervention ] |
Target number/sample size
30 (15 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2024-05-01
Anticipated end date
2024-11-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Not applicable
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-02-27
Approval number
2023/EC/71
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya. |
| Institutional Address: | Faculty of Medicine, University of Peradeniya, No: 34, Galaha Rd, Kandy |
| Telephone: | 0812 396 000 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Ranil Jayawardena
Professor in Nutrition
The Faculty of Medicine, University of Colombo, No. 25, Kynsey Road, Colombo 8,
+94 112 695 300
0718323332
ranil@physiol.cmb.ac.lk
Contact Person for Public Queries
Ranil Jayawardena
Professor in Nutrition
The Faculty of Medicine, University of Colombo, No. 25, Kynsey Road, Colombo 8,
+94 112 695 300
0718323332
ranil@physiol.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Not Applicable
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
