The objective of this study is to evaluate the effects of intake of Royal Jelly in type 2 diabetes. A total of 50 patients with type 2 diabetes, who referred to Endocrine and Metabolism Institue of Tehran University of Medical Sciences, will be allocated to 2 groups by stratified randomization method. They will receive 3 capsules of royal jelly (1000 mg) daily for 8 weeks in the intervention group and placebo in the control group. Serum total antioxidant capacity ,malondialdehyde,interleukin-6, 24-hour dietary recall, none consecutive 3- day 24-hour dietary recalls (including 2 usual days and one holiday) will be assessed and compared at the first week, at the end of 4th week, and at the end of the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103012709N18
Registration date:2011-03-14, 1389/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-14, 1389/12/23
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2011-06-05, 1390/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Royal Jelly intake on serum total antioxidant capacity,malondialdehyde and interleukin-6 levels in type 2 diabetic patients
Public title
Effects of intake of royal jelly in type 2 diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: confirmed diabetes type 2 based on physicians diagnosis, being volunteer or willingness to attend, no history of cardiovascular, liver or kidney diseases, not receiving insulin prior to 3 months before the trial, age between 20-65 years old, HbA1c 6-8%, no allergy to honey or its products, BMI between 20-30, duration of type 2 diabetes mellitus for 5 -10 years, no history of smoking and alcohol drinking Exclusion criteria: cholesterol >=240mg/dl, TG>=400mg/dl, incomplete consumption of royal jelly, creation of allergy during the study period, using of any kind of food supplements, pregnancy, lactation, using of oral contraceptive pills, changing medication dosage
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
next to Milad tower, Shahid Hemmat
City
Tehran
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
2402
Health conditions studied
1
Description of health condition studied
DIABETES MELLITUS
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
total antioxidant capacity
Timepoint
Before and after the intervention
Method of measurement
plasma antioxidant activity ,FRAP method
2
Description
serum malondialdehyde
Timepoint
Before and after the intervention
Method of measurement
fast plasma malondialdehyde level,spectrophotometry
3
Description
interleukin-6
Timepoint
Before and after the intervention
Method of measurement
fast plasma interleukin-6,ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 royal jelly (1000mg) capsules daily
Category
Prevention
2
Description
Control group: placebo 3 (1000mg) capsules daily
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine and Metabolism Institute of Tehran University of Medical Sciences