| CTRI Number |
CTRI/2014/06/004666 [Registered on: 12/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
15/12/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of consumption of red raw and red parboiled rice on blood glucose and lipid levels in diabetes |
|
Scientific Title of Study
|
Effects of red raw and red parboiled rice on the glycemic control in type 2 diabetes mellitus patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadarshika Hettiarachchci |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Department of Physiology,
Faculty of Medical Sciences,
University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
37A Yahampath Mawatha, Godigamuwa, Maharagama, Sri Lanka
0000
Other |
| Phone |
094112758576 |
| Fax |
0941811480 |
| Email |
priyadarshikahett@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R A D Upul Cosmon |
| Designation |
PG student |
| Affiliation |
Nursing Unit,Faculty of Medical Sciences,University of Srijayewardenapura. |
| Address |
Nursing Unit,
Faculty of Medical Sciences,
University of Sri Jayewardenepura, Gangodawila, Nugegoda.SriLanka.
0000
Other |
| Phone |
094112758601 |
| Fax |
094112801604 |
| Email |
ucosman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyadarshika Hettiarachchci |
| Designation |
Associate Professor |
| Affiliation |
Dept of Physiology,University of SriJayewardenapura,SriLanka. |
| Address |
Department of Physiology,
Faculty of Medical Sciences,
University of Sri Jayewardenepura, Gangodawila, Nugegoda,SriLanka.
No: 37A YahampathMawatha,Maharagama,SriLanka.
0000
Other |
| Phone |
|
| Fax |
094112801604 |
| Email |
priyadarshikahett@gmail.com |
|
|
Source of Monetary or Material Support
|
| University of Sri jayewardenepura, University research grant. Grant no: ASP/06/R/2009/02 |
|
|
Primary Sponsor
|
| Name |
University of Sri Jayewardenepura |
| Address |
Gangodawila, Nugegoda, Sri Lanka. |
| Type of Sponsor |
Other [University of SriJayewardenapura,Sri Lanka] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Sri Lanka |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ProfPHettiarachchi |
Welikada Prison, |
Department of Prisons, No.150, Baseline Road, Colombo 09, Sri Lanka.
|
094718432344
priyadarshikahett@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Faculty of Mecdical Sciences, University of Sri Jayewradenepura, GAngodawila, Nugegoda,Srilanka. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type II Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Red Parboiled rice consumption for 16 weeks |
Red parboiled rice consumption for 16 weeks as the staple thrice daily |
| Intervention |
Red Raw rice consumption for 16 weeks |
Red raw rice consumption for 16 weeks as the main staple thrice daily |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Suffering from type II diabetes mellitus. |
|
| ExclusionCriteria |
| Details |
• Those who were on treatment for any diseases such as diabetes, hypertension, hypercholesteraleamia were excluded from the study when their medications were changed due to any reason.
• Advanced complications of diabetes, such as retinopathy with laser treatment, neuropathy with renal impairment and extensive diabetic ulcers.
• Those who receive insulin therapy.
• Those who did not consume rice as the staple food.
• Patients who did not understand English and/or Sinhala language
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in BMI, Lipid profile and Blood glucose levels |
Improvement in BMI (to below 23, Lipid profile (to normal levels for HDL, LDL, Total cholesterol, HDL:TC ratio and triglycerides) and Blood glucose levels (below 110mg/dl)at the end of 4, 8, 12 and 16 weeks of consuming the two rice varieties |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in BMI, Lipid profile and Blood glucose levels |
At the end of 4, 6, and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/10/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Identifying a healthy rice variety has substantial health benefits for type two diabetes mellitus
Patients (T2DM). Parboiled rice consumption is known to reduce glycaemic response. Neither
glycaemic responses, nor lipid profile, BMI in diabetes after consumption of red parboiled and red raw rice has been explored. Aim of this study was to determine the impact of red parboiled rice consumption vs to red raw rice on glycaemic response, lipid profile and BMI in T2DM. This analytical crossover study included diabetics (aged 40-70yrs) registered at Prison Hospital, Sri Lanka. The 69 subjects who completed the study were served 180g of red raw in the first 16weeks and red parboiled rice in the next 16 weeks.
Two ml each of venous blood was collected after an overnight fast at 0,4,8,16 weeks for fasting
blood glucose and at 0, 16 weeks for glycated haemoglobinand lipid profile respectively.BMI was assessed weekly. Results while consuming red raw and red parboiled rice were compared using ANOVA repeated measures, General Linear Model.During consumption of red raw rice the BMI (p=0.009) and fasting blood glucose (p= 0.001)reduced only at 8weeks. During consumption of red parboiled rice fasting blood glucose reduction was significant at 8weeks (p=0.006), 12 weeks ( p=0.002), and 16 weeks (p=0.005) whereas BMI showed a significant reduction at 8 weeks (p=0.028) and 16 weeks (p=0.003). At the end of 16weeks consumption of red parboiled rice the LDL, TC, TC/HDL value was significantly lower respectively (p= 0.001, p= 0.013, p=0.032) whereas none of the lipid markers were altered while consuming red raw rice. These results suggest that red parboiled rice consumption could be used as a novel approach in reducing the glucose, lipid metabolism markers and BMI in diabetes mellitus. |