| CTRI Number |
CTRI/2025/01/079299 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of low inflammatory diet on performance of athletes |
|
Scientific Title of Study
|
Evaluation of Dietary Approach for Reduced Inflammation and Enhanced Recovery (DARIER) as a nutritional strategy to modulate inflammatory markers, immune function and fatigue in athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Sanghi |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Room No-QF-10,Q Block, Department of Nutrition and Dietetics, Manav Rachna International Institute of Research and Studies,
Sector 43, Aravalli Hills,
Delhi-Surajkund Road,
Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
07838216486 |
| Fax |
|
| Email |
divya.sahs@mriu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Sanghi |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies,
Sector 43, Aravalli Hills,
Delhi-Surajkund Road,
Faridabad, Haryana
HARYANA
121004
India |
| Phone |
07838216486 |
| Fax |
|
| Email |
divya.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Sanghi |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies,
Sector 43, Aravalli Hills,
Delhi-Surajkund Road,
Faridabad, Haryana
HARYANA
121004
India |
| Phone |
07838216486 |
| Fax |
|
| Email |
divya.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Ministry of Youth Affairs and Sports,Room No 401,C-Wing, Shastri Bhawan New Delhi - 110001, India |
|
|
Primary Sponsor
|
| Name |
Ministry of Youth Affairs and Sports |
| Address |
Room No. 401, C-Wing, Shastri Bhawan, New Delhi, Delhi 110001 |
| 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 |
| Divya Sanghi |
Manav Rachna International Institute of research and Studies |
Manav Rachna International Institute of Research and Studies, Sector-43
Sector 43, Aravalli Hills,
Delhi-Surajkund Road,
Faridabad, Haryana
Faridabad
HARYANA |
07838216486
divya.sahs@mriu.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee, MRIIRS, Faridabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DARIER |
The intervention consists of 3 months. i.Participants will receive personalized dietary counseling based on the DARIER approach which they will be advised to follow for 3 months.
ii.The DARIER approach emphasizes the consumption of anti-inflammatory foods such as fruits, vegetables, whole grains, lean proteins, and omega-3 fatty acids while minimizing pro-inflammatory foods such as refined sugars, processed meats, and trans fats.
iii. Participants will be provided with dietary guidelines, meal plans, and recipes tailored to their individual needs and preferences.
|
| Comparator Agent |
Standard care |
i. Participants will be instructed to maintain their regular dietary habits throughout the study period (3 months).
ii. They will receive general dietary advice on maintaining a balanced diet for athletic performance but will not receive specific guidance on the DARIER approach.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
i. Endurance athletes aged 18-28 years, long distance runners, participants of state and University level will be recruited in the study.
ii.Engaged in regular endurance training for the past 3 or more years.
iii. No history of chronic diseases or metabolic disorders.
|
|
| ExclusionCriteria |
| Details |
i.Presence of any chronic medical conditions affecting dietary intake, metabolism, or exercise performance.
ii. Use of medications or supplements known to affect inflammatory markers, immune function.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Inflammatory Markers: Assessment of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) levels.
ii. Immune Function: Evaluation of immune cell counts (lymphocytes and neutrophils) interleukin-4 (IL-4).
|
At baseline and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Performance Measures: Endurance performance tests (VO2 max test).
ii. Subjective Measures: Self-reported fatigue levels
|
baseline, 1.5 months and 3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/02/2025 |
| 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="2"
Months="0"
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
|
Introduction: Endurance athletes experience complex physiological responses like inflammation, and immune function alterations during training. Dietary choices, particularly those with a high Dietary Inflammatory Index (DII), can impact these responses. A low DII diet potentially benefits athletes by reducing inflammation, supporting immunity, and enhancing recovery. Methods: This randomized controlled trial will investigate the effects of the DARIER diet (low DII) on athletes (n=80) over 12 weeks. Participants will be randomized to either the intervention group receiving the DARIER diet or the control group maintaining their usual diet. Primary outcomes include changes in inflammatory markers, and immune function. Secondary outcomes include performance measures and self-reported fatigue levels. Discussion: This study will contribute to understanding the impact of the DARIER diet on athlete health and performance. If effective, the DARIER approach could provide evidence-based dietary recommendations for athletes, improving their health, recovery, and performance. |