The Effect of royal jelly supplementation on serum antioxidants status, lipid profiles, insulin resistance and glucose level and inflammatory factors in type 2 diabetes
This randomized clinical trial is designed to determine the effect of royal jelly supplementation on serum antioxidants status, lipid profiles, insulin resistance, glucose level and inflammatory factor in type 2 diabetes.
Fifty patients with type 2 diabetes will be randomly divided in 2 groups including 25 patients in intervention group (which will be receive royal jelly tablets) and 25 patients in control group. The intervention group will be received 1000 mg royal jelly tablets, however the control group will be received 1000 mg paraffin tablet every day for two months. The antioxidant indices, lipid profile and insulin resistance and fasting blood glucose will be measure before and after study. Also for assessment of food intake and appetite, 24 hours food recall and appetite questionnaire will be completed before and after study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011131197N5
Registration date:2011-02-28, 1389/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-28, 1389/12/09
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center Of Tabriz University Of Medical Sciences
Expected recruitment start date
2010-12-11, 1389/09/20
Expected recruitment end date
2011-02-09, 1389/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of royal jelly supplementation on serum antioxidants status, lipid profiles, insulin resistance and glucose level and inflammatory factors in type 2 diabetes
Public title
The effect of royal jelly supplementation on type2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 30-65 years old, BMI 25 until 30, having diabetes at least 6 months prior to the study, consumption of blood glucose lowering drugs
Exclusion criteria: consumption of antioxidants supplements during last 3 month prior to the study, using insulin, pregnancy, lactation, acute renal disease, hypothyroidism, hyperthyroidism, allergy
Age
From 30 years old to 65 years old
Gender
Female
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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Attar Neyshabori Street, Tabriz, East Azerbayjan, Iran, Islamic Republic Of
City
Tabriz
Postal code
Approval date
2010-11-14, 1389/08/23
Ethics committee reference number
8939
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
serum antioxidant status
Timepoint
8weeks
Method of measurement
measurment of SOD,GPX-H,TAC,MDA
2
Description
lipid profiles
Timepoint
8 weeks
Method of measurement
TC, TG, LDL, HDL
3
Description
insulin level
Timepoint
8 weeks
Method of measurement
Serum level of insulin
4
Description
blood glucose
Timepoint
8 weeks
Method of measurement
fasting blood glucose
5
Description
Inflammatroy factors
Timepoint
8 weeks
Method of measurement
HS-CRP
Secondary outcomes
1
Description
Anthropomethric indices
Timepoint
8 Weeks
Method of measurement
Weight, Height, BMI
2
Description
appetite
Timepoint
8 weeks
Method of measurement
questionnaire
3
Description
dietary intake
Timepoint
8weeks
Method of measurement
24 hours-food recal questionnaire
Intervention groups
1
Description
intervention group: 1000 mg/day royal jelly tablet with breakfast for 8 weeks
Category
Treatment - Drugs
2
Description
Placebo group: 1000 mg/day placebo tablet (containing edible paraffin) with breakfast for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic Of Sina Hospital
Full name of responsible person
Dr. Mobasseri
Street address
Sina Hospital- Hafez Square- Azadi Street- Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Research Center, Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Ostadrahimi
Street address
Block B, Third Floor, Health And Nutrition Faculty, Tabriz University Of Medical Sciences , Attar Neyshabori Street,Tabriz, East Azerbayjan,Iran, Islamic Republic Of
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Research Center, Tabriz 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
Nutritional Research Center, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Reza Mahdavi
Position
Nutritional Research center, Tabriz University Of Medical Sciences
Other areas of specialty/work
Street address
Tabriz Medical University
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
Mahdavir@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Samira Pourmoradian
Position
Master Science Student Of Nutrition
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
samira.pourmoradian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Samira Pourmoradian
Position
Master Science Student Of Nutrition
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)