Home » Trials » SLCTR/2013/021
Oral hypoglycaemic and anti-inflammatory activity of P.ostreatus and P.cystidiosus on diabetic subjects, who are on diet control
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SLCTR Registration Number
SLCTR/2013/021
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Oral hypoglycaemic and anti-inflammatory activity of P.ostreatus and P.cystidiosus on diabetic subjects, who are on diet control
Public Title of Trial
Oral hypoglycaemic activity of Pleurotus mushrooms on diabetic subjects
Disease or Health Condition(s) Studied
Diabetes mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Oral hypoglycaemic activity of Pleurotus mushrooms on diabetic subjects
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
380/8 and 599/11 (Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura)
What is the research question being addressed?
What is the effect of a single dose of culinary P. ostreatus and P. cystidiosus mushrooms on the blood sugar of diabetic patients on diet control?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Crossover
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
All patients who present to the Family Practice Centre, Faculty of Medical Sciences, University of Sri Jayewardenepura within the inclusion criteria will be considered for the study.
Consenting patients will be divided into 2 groups. Group 1 will receive P. ostreatus and group 2 will receive P. cystidiosus.
On day 1, patients will receive a placebo (distilled water). Glucose load will be given 30 minutes after administration of the placebo. Standard glucose tolerance test will be performed. (75 g glucose in 300 ml water).Blood samples (3ml) will be collected by venepuncture, 2 hours after the glucose load, for the estimation of blood glucose concentrations.
On day 8, a single dose of freeze dried and powdered P. ostreatus or P. cystidiosus at a dose of 50 mg/kg will be administered. The mushroom will be administered as a suspension in water to each patient according to their respective group.
Glucose load will be given 30 minutes after administration of the mushroom suspension. Standard glucose tolerance test will be performed.
At the end of 4 weeks, liver function and renal function will be determined.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Fasting blood glucose |
[ Prior to administration of the mushroom suspension ] |
|
2.
Post glucose loaded (OGTT) blood glucose |
[ 2 hours after glucose load. ] |
|
3.
Serum insulin levels (using ELIZA kits) |
[ 2 hours after glucose load. ] |
Secondary outcome(s)
|
1.
Change in liver function : serum alanine amino transferase, aspartate amino transferase, alkaline phosphatase, gamma glutamyl transpeptidase |
[ At base line and at the end of 4 weeks ] |
|
2.
Change in renal function : serum creatinine |
[ At baseline and at the end of 4 weeks ] |
Target number/sample size
28 patients (14 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-07-01
Anticipated end date
2013-08-31
Date of first enrollment
2013-06-25
Date of study completion
Recruitment status
Recruiting
Funding source
World Class University Project, University of Sri Jayewardenepura, WCUP PhD/04/2012
Regulatory approvals
Status
Approved
Date of Approval
2012-03-29
Approval number
599/11
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Primary study sponsor/organization
University of Sri Jayewardenepura
Gangdawilla, Nugegoda
0112802696
unisj@sjp.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
