A Clinical trail to compare White Button Mushroom (Agaricus Bisporus) powder with corn starch on levels of glycemic indices, lipid profile , serum hs - CRP, ergothioneine and total antioxidant capacity in type 2 diabetic patients
The objective of this study is the evaluation the effects of White Button Mushroom (Agaricus Bisporus) powder on some of glycemic indices, lipid profile, serum levels of hs-CRP, ergothioneine and total antioxidant capacity in type 2 diabetic patients. In this double blind randomized clinical trial, 44 diabetic patients are selected and allocated to two groups involve intervention (n=22) and control (n=22) groups. Blinding will be implemented on patients and researchers. The period of intervention is 8 weeks. Main inclusion criteria: type 2 diabetic patients who have been suffering from the disease for at least 2 years and have been using diabetic drugs for more than 6 month. Main Exclusion criteria: using insulin therapy, allergic to mushrooms and major medical conditions. The intervention group receives mushroom powder (16 gr daily) and the control group receives corn starch powder as placebo (16 gr daily) for 8 weeks. Some demographic data including age, sex; anthropometric indices such as weight, height, BMI, waist and hip circumference; biochemical indices including fasting blood glucose, total antioxidant capacity, high sensitive C-reactive protein and a 24 hour recall are evaluated pre and post intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062534760N1
Registration date:2017-09-27, 1396/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Hadiseh Hashemi yosefabad
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 917 145 7681
Email address
hashemi.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-04-18, 1396/01/29
Expected recruitment end date
2017-07-20, 1396/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trail to compare White Button Mushroom (Agaricus Bisporus) powder with corn starch on levels of glycemic indices, lipid profile , serum hs - CRP, ergothioneine and total antioxidant capacity in type 2 diabetic patients
Public title
Effect of White Button Mushroom in treatment of diabetic patients with type 2 diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetic patients who have been suffering from the disease for at least 2 years and have been using diabetic drugs for more than 6 month; BMI between 20 and 35 kg/m2.
Exclusion criteria: using insulin therapy; Smoking; pregnancy; breast feeding; Weight loss greater than 10% of body weight in the past 6 months; being currently on a weight-loss diet or program; allergic to latex; allergic to mushrooms; consuming mushroom more than once or twice a week; major medical conditions (such as renal failure, heart failure, inflammatory diseases, hepatitis); using immunosuppressive; NSAIDs; diuretic; estrogen medications; using any dietary supplements including antioxidant, fiber, omega 3.
Age
From 23 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Assignment of patients to each groups is done by random block method using block of size 4.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Science
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khosetan, Iran
City
Ahvaz
Postal code
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.AJUMS.REC.1396.381
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
before and after intervention
Method of measurement
Using enzymatic kit method
2
Description
Insulin
Timepoint
before and after intervention
Method of measurement
ElISA
3
Description
Fructosamine
Timepoint
before and after intervention
Method of measurement
ElISA
4
Description
LDL cholestrol
Timepoint
before and after intervention
Method of measurement
Using enzymatic kit method
5
Description
HDL cholestrol
Timepoint
before and after intervention
Method of measurement
Using enzymatic kit method
6
Description
VLDL cholestrol
Timepoint
before and after intervention
Method of measurement
Using enzymatic kit method
7
Description
Triglyceride
Timepoint
before and after intervention
Method of measurement
Using enzymatic kit method
8
Description
Total cholestrol
Timepoint
before and after intervention
Method of measurement
Using enzymatic kit method
9
Description
hs-CRP
Timepoint
before and after intervention
Method of measurement
ElISA
10
Description
TAC
Timepoint
before and after intervention
Method of measurement
ElISA
11
Description
Ergothioneine
Timepoint
before and after intervention
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: The intervention group receive 16 gr mushroom powder twice a day with food (8 grams per meal), daily for 8 weeks.
Category
Other
2
Description
Control: The control group receive 16 gr corn starch powder twice a day with food (8 grams per meal), daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Golestan Hospital
Full name of responsible person
Dr Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khosetan, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khosetan,Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Hadiseh Hashemi yusefabad
Position
Master student in Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Khosetan,Iran
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
hashemihadis@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Seyyed Ahmad Hosseini
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan highway, Avaz, Khozestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
seyedahmadhosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hadiseh Hashemi yusefabad
Position
Master student in Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan highyway, Ahvaz, Khozestan, Iran