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CTRI Number  CTRI/2017/07/009022 [Registered on: 11/07/2017] Trial Registered Retrospectively
Last Modified On: 10/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Cashew Nut Supplementation on Body Weight, Glycemic and Lipid Profile in Asian Indian Adults with Type 2 Diabetes 
Scientific Title of Study   Effect of cashew nut supplementation on glycemic status and lipid profile in type 2 diabetic subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Mohan 
Designation  President and Chief of Diabetes Research 
Affiliation  Madras Diabetes Research Foundation  
Address  No 4, Conran Smith Road Gopalapuram, Chennai

Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  drmohans@diabetes.ind.in  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Sudha Vasudevan 
Designation  Sr Scientist and Head 
Affiliation  Madras Diabetes Research Foundation  
Address  No 4, Conran Smith Road Gopalapuram, Chennai

Chennai
TAMIL NADU
600086
India 
Phone    
Fax    
Email  s2r_7@mdrf.in  
 
Details of Contact Person
Public Query
 
Name  Mrs Sudha Vasudevan 
Designation  Sr Scientist and Head 
Affiliation  Madras Diabetes Research Foundation  
Address  No 4, Conran Smith Road Gopalapuram, Chennai


TAMIL NADU
600086
India 
Phone    
Fax    
Email  s2r_7@mdrf.in  
 
Source of Monetary or Material Support  
The Cashew Export Promotion Council of India Cashew Bhavan Mundakkal West Kollam 691001 Kerala India  
 
Primary Sponsor  
Name  Madras Diabetes Research Foundation 
Address  No 4, Conran Smith Road, Gopalapuram, Chennai - 600 086 
Type of Sponsor  Research institution 
 
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 V Mohan  Department of Foods Nutrition and Dietetics Research,Madras Diabetes Research Foundation  No 4, Conran Smith Road, Gopalapuram, Chennai - 600 086
Chennai
TAMIL NADU 
43968888

drmohans@diabetes.ind.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Madras Diabetes Reseach Foundation Institution Ethics Committee  Approved 
Madras Diabetes Reseach Foundation Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 diabetic patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cashew nut   30 g of cashew nut was provided to the participants who were randomized to intervention group for 3 months 
Comparator Agent  Only Diet Counseling  For the participants randomized to this group were given diet counselling and considered as Control group for 3 months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Type 2 diabetic subjects
Only with oral hypoglycemic agents [OHA] ie., metformin, Gliptins and / or sulphonylureas,
HbA1c between 7.0 -11.0 %
Willing to follow study protocol
Willing to give informed consent
 
 
ExclusionCriteria 
Details  1.Subjects with known allergy to cashew nuts
2.Subjects on statins
3.Subjects on insulin
4.LDL cholesterol > 190 mg/dl
5.Total serum cholesterol >240 mg/dl
6.Serum Triglycerides > 300 mg/dl
7.Any acute infections
8.Chronic diseases such as tuberculosis, disorders of liver, kidney, heart, lungs and other organs etc.
9.Pregnant and lactating Women
 
 
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 
To assess changes in glycemic, and lipid profile among type 2 diabetic subjects by daily supplementation of cashew nuts in their diets  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
2. To evaluate the effects of daily cashew nut supplementation on anthropometric measurements and clinical indicators of general health  3 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   08/04/2014 
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="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 There is a rapid increase in the prevalence of type 2 diabetes worldwide and the morbidity and mortality associated with the disease is a major concern especially in the developing countries like India. Primary intervention through diet and lifestyle modification assumes paramount importance in the prevention and management of diabetes. Studies have shown that reduction in the incidence of diabetes can be achieved over long period through modest dietary changes, weight loss and exercise. With increasing awareness on the effect of refined grains on postprandial hyperglycemia and reduction in HDL cholesterol, replacement of carbohydrate by healthy fat, such as monounsaturated fatty acids (MUFAs) and polyunsaturated fatty acids (PUFAs), has been increasingly recognized as a possible therapeutic strategy in the treatment of diabetes. 

Nuts are energy dense foods and the unique nutrient composition of nuts may confer metabolic benefits and reduce the risk of developing coronary heart disease (CHD) and diabetes. Independent clinical studies have shown multiple beneficial effects of nut consumption such as weight loss, reduced inflammation and cardiovascular disease risk. Higher nut consumption is associated with a reduced risk of diabetes and of the development of coronary heart disease in individuals with diabetes.Cross sectional studies have shown decreased levels of soluble inflammatory markers and increase in serum adiponection concentration upon nut consumptionCashew nuts are one of the commonly consumed nuts in the Indian population. Various studies have demonstrated the beneficial properties of cashew nuts in animal models. A recent clinical study have shown two ounces of nuts daily as a replacement for carbohydrate foods improved both glycemic control and serum lipids in type 2 diabetes. Not many studies have been done on the health benefits of nuts specifically in the diabetic subjects in the Indian population. The aim of this study will be to look at the effect of cashew nut consumption on the glycemic and lipid profile in the chosen type 2 diabetic subjects.

 
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