| 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
|
|
|
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
|
|
|
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 consumption. Cashew 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. |