FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062758 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutrition Intervention]  
Study Design  Single Arm Study 
Public Title of Study   Anti-inflammatory diet for chronic kidney disease 
Scientific Title of Study   Impact of nutrition intervention on clinical and metabolic outcomes in pre-dialysis CKD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prathiksha R Bhat 
Designation  UGC - Senior Research Fellow 
Affiliation  University of Mysore 
Address  Department of Studies in Food Science and Nutrition, Manasagangotri campus, University of Mysore

Mysore
KARNATAKA
570006
India 
Phone  8951638616  
Fax    
Email  prathiksha.bhat27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Asna Urooj 
Designation  Professor and Chairperson 
Affiliation  University of Mysore 
Address  Department of Studies in Food Science and Nutrition, Manasagangotri campus, University of Mysore

Mysore
KARNATAKA
570006
India 
Phone  9448489334  
Fax    
Email  asnaurooj@foodsci.uni-mysore.ac.in  
 
Details of Contact Person
Public Query  
Name  Prathiksha R Bhat 
Designation  UGC - Senior Research Fellow 
Affiliation  University of Mysore 
Address  Department of Studies in Food Science and Nutrition, Manasagangotri campus, University of Mysore

Mysore
KARNATAKA
570006
India 
Phone  8951638616  
Fax    
Email  prathiksha.bhat27@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support for the trial extended by University of Mysore 
University Grants Commission -Junior Research Fellow Award. UGC-Ref.No: 1593/(NET-DEC 2018)  
 
Primary Sponsor  
Name  Prathiksha R Bhat 
Address  Department of Studies in Food Science and Nutrition, Manasagangotri campus, University of Mysore 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asna Urooj  Department of Studies in Food Science and Nutrition  Nutrition Counselling room, Ground Floor, Department of Studies in Food Science and Nutrition, Manasagangotri campus, University of Mysore
Mysore
KARNATAKA 		 9448489334

asnaurooj@foodsci.uni-mysore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee - University of Mysore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, (2) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (3) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (4) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (5) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (6) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (7) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anti-inflammatory diet for chronic kidney disease  Intervention type: Anti-inflammatory dietary pattern for chronic kidney disease patients (per dietary inflammatory index score). Description of the pattern: The schedule consists of commonly consumed food items and recipes in a structured 7-day recommended pattern taking into account the individual needs and requirements as per recommendations by KDIGO, KDOQI, ICMR-NIN and Indian Society of Nephrology guidelines. Duration of the intervention: 6 weeks (with regular follow-up of the outcome variables and regular adjustments to the diet based on the outcome measures) 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosed Chronic Kidney Disease patients with or without diabetes, hypertension and cardiovascular disease.  
 
ExclusionCriteria 
Details  Patients on dialysis, renal transplant recipients, with physiological alterations such as pregnancy/lactation, physical impairment/disabilities, recent history of trauma, infection, major surgery or any other chronic catabolic illness such as COPD, cancer etc  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum creatinine and estimated glomerular filtration rate (CKD-EPI equation, 2009)  0th and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
Serum creatinine and estimated glomerular filtration rate (CKD-EPI equation, 2009)  3rd week 
Inflammatory marker - CRP by LEIT method  0th, 3rd and 6th week 
Oxidative stress marker - Malondialdehyde by TBARS method  0th, 3rd and 6th week 
Total antioxidant capacity - FRAP and uric acid independent FRAP assay  0th, 3rd and 6th week 
Serum electrolytes, phosphorous, calcium, protein, albumin (kit methods)  0th, 3rd and 6th week 
Lipid profile - Triglycerides, cholesterol, HDL-C (enzymatic kit methods), calculated LDL-C (Martin Hopkins equation)  0th, 3rd and 6th week 
Quality of Life - KDQOL-36 SF questionnaire  0th and 6th week 
Body composition analysis by a multi-frequency bio-impedance-based analyzer, InBody 770  0th, 3rd and 6th week 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/02/2024 
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="1"
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  

The current study is a single-arm interventional trial to assess the effect of an anti-inflammatory dietary pattern on disease-related biochemical parameters, body composition and quality of life in pre-dialysis CKD patients. Patients will be advised to follow a 7-day anti-inflammatory dietary pattern, personalized according to their nutrient recommendations and disease stage, for a minimum of 6 weeks. The pattern will consist of commonly consumed and available recipes and foods, formulated into a meal pattern. The anti-inflammatory nature of the diet during planning and measuring the impact of the proposed meal plan will be quantified using a dietary inflammatory index score algorithm via multiple 24-hour recalls. The primary outcome of the study will be markers of disease progression, i.e. serum creatinine and estimated glomerular filtration rate, measured at baseline and the end of the study period. Other outcomes such as markers of inflammatory status, oxidative stress, total antioxidant capacity, body composition measured by a multi-frequency bioimpedance-based analyzer and quality of life using the KDQOL SF-36 questionnaire will also be assessed.

 
Close