| CTRI Number |
CTRI/2025/11/097535 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [our study involved healthy athletes receiving dietary interventions] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Different Diets for Endurance Runners: Low Glycemic, High Glycemic, and Keto |
|
Scientific Title of Study
|
Comparative Effects of Low Glycemic Index, High Glycemic Index, and Ketogenic Diets on Body Composition, Fat Analysis and Vo2 max in Endurance Athletes over 12 weeks |
| 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 Harpreet Kour |
| Designation |
Associate Professor |
| Affiliation |
KLE Academy of Higher Eductaion and Research Belagavi |
| Address |
Staff Room, Cabin 3,
Department of Physiology,
Ground Floor
Jawaharlal Nehru Medical College,
KLE Academy of Higher Education and Research,
Belagavi, Karnataka
Pincode: 590010
Email Id: harpreet.kour@yahoo.co.in
Belgaum
KARNATAKA
590010
India |
| Phone |
9620850326 |
| Fax |
|
| Email |
harpreet.kour@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kour |
| Designation |
Associate Professor |
| Affiliation |
KLE Academy of Higher Eductaion and Research Belagavi |
| Address |
Staff Room, Cabin 3,
Department of Physiology,
Ground Floor
Jawaharlal Nehru Medical College,
KLE Academy of Higher Education and Research,
Belagavi, Karnataka
Pincode: 590010
Email Id: harpreet.kour@yahoo.co.in
Belgaum
KARNATAKA
590010
India |
| Phone |
9620850326 |
| Fax |
|
| Email |
harpreet.kour@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harpreet Kour |
| Designation |
Associate Professor |
| Affiliation |
KLE Academy of Higher Eductaion and Research Belagavi |
| Address |
Jawaharlal Nehru medical College, KLE Academy of Higher Education and Research Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9620850326 |
| Fax |
|
| Email |
harpreet.kour@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Harpreet Kour |
| Address |
Dr Harpreet Kour,
Associate Professor,
Staff Room, Cabin 3,
Department of Physiology,
Ground Floor
Jawaharlal Nehru Medical College,
KLE Academy of Higher Education and Research,
Belagavi, Karnataka, India
Pincode: 590010
Email Id: harpreet.kour@yahoo.co.in Belagavi |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Harpreet Kour |
KLE Academy of Higher Eductaion and Research Belagavi |
Exercise Research Laboratory,
Department of Physiology,
Ground Floor,
Jawaharlal Nehru Medical College,
KLE Academy of Higher Education and Research,
Belagavi, Karnataka
Pincode: 590010
Belgaum
KARNATAKA |
09620850326
harpreet.kour@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fifty-seven healthy male endurance athletes from Karnataka, India |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Low-GI) |
The total duration of the dietary intervention for each participant in Group A will be 12 weeks. The diet will comprise approximately 55-60% of total daily energy intake from carbohydrates, with 65% of these carbohydrate calories derived from low-glycemic index sources (GI 55). The total duration of each study participants involvement, including baseline (Week 0) and post-intervention (Week 13) assessments, will be 13 weeks. |
| Intervention |
Group B (High-GI) |
The total duration of the dietary intervention for each participant in Group B will be 12 weeks. The diet will comprise approximately 55-60% of total daily energy intake from carbohydrates, with 65% of these carbohydrate calories derived from high-glycemic index sources (GI 70). The total duration of each study participants involvement, including baseline (Week 0) and post-intervention (Week 13) assessments, will be 13 weeks. |
| Comparator Agent |
Group C (LCHF/Ketogenic) |
The total duration of the dietary intervention for each participant in Group C will be 12 weeks. The diet will comprise 70% of total daily energy intake from fat, 15-20% from protein, and 50 g of carbohydrates daily. The total duration of each study participants involvement, including baseline (Week 0) and post-intervention (Week 13) assessments, will be 13 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Healthy Male endurance athletes with minimum of 2 years of endurance training, and who are running more than 40 kms per week will be recruited in the study |
|
| ExclusionCriteria |
| Details |
participants with cardio metabolic disorders, BMI more than 30 kg/m2, recent significant changes in diet or training, history of smoking or alcohol consumption will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| trial to compare the effects of these three dietary approaches combined with a periodized endurance training program on body composition, aerobic capacity, and metabolic health in trained male endurance athletes. |
The outcomes were measured at two specific time points: once before the start of the intervention (Baseline, Week 0) and once immediately after the completion of the 12-week intervention period (Post-intervention, Week 12). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Blood Lipid Profile, Fasting Blood Glucose, Thyroid-Stimulating Hormone (TSH) levels, Training Volume and percieved exertion |
Baseline and at the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
30/11/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [harpreet.kour@yahoo.co.in].
- For how long will this data be available start date provided 01-06-2026 and end date provided 10-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
1. The pursuit of excellence in endurance sports necessities a holistic approach that integrates meticulous training programming with precise nutritional interventions. Despite the proposed mechanistic benefits of dietary strategies, a critical dearth of direct comparative evidence exists. The current literatures characterized by studies investigating these diets in isolation, often with heterogenous participants or non-standardized training interventions. 2. Therefore, the study has been planned to bridge this gap by conducting a randomized controlled trial to compare the effects of these three dietary approaches combined with a periodized endurance training program on body composition, aerobic capacity and metabolic health in trained endurance athlete. |