This study aimed to investigate the effect of a single dose of royal jelly on serum glucose, insulin and c-peptide in type 2 diabetic patients. Forty patients with type 2 diabetes will be randomly divided in 2 groups including 20 patients in the intervention group and 20 patients in the control group. After explaining the study procedure for the patients and informed consent, in the morning after an 8-hour fasting blood sample will be taken. The intervention group will be received 10 g royal jelly, however the control group will be received 10 g paraffin. One and two hours after administration, blood samples will be obtained. Serum glucose, insulin and C-peptide in each sample will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306049626N2
Registration date:2013-06-13, 1392/03/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-13, 1392/03/23
Registrant information
Name
Majid Mobaseri
Name of organization / entity
Tabriz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
t.u.end.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Bone disease health center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single dose of royal jelly on serum glucose, insulin and C-peptide level in type 2 diabetic patients.
Public title
Effect of royal jelly on serum glucose and insulin in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having type 2 diabetes; age 30-65 years old; treated with glucose-lowering drugs.
Exclusion criteria: insulin therapy; history of allergy to honey or bee products; pregnancy; lactation; renal failure; a history of any type of metabolic disease other than type 2 diabetes such as proved thyroid disease.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Faculty of Medicine- Daneshgah Ave. Tabriz
City
Tabriz
Postal code
Approval date
2013-05-13, 1392/02/23
Ethics committee reference number
9235
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
Plasma glucose levels
Timepoint
Before and one hour and two hour after intervention
Method of measurement
Paraclinical
2
Description
Plasma insulin levels
Timepoint
Before and one hour and two hour after intervention
Method of measurement
Paraclinical
3
Description
Plasma C-peptide levels
Timepoint
Before and one hour and two hour after intervention
Method of measurement
Paraclinical
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:10 g royal jelly in morning after an 8-hour fasting
Category
Treatment - Drugs
2
Description
Placebo group: 10 g placebo tablet (containing edible paraffin) jelly in morning after an 8-hour fasting
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr. Majid Mobaseri
Street address
Imam Reza hospital- Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shakuri Kazem
Street address
Golgasht Street ,Tabriz University of Medical Sciences ,central building II,third floor
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Mobaseri
Position
Associate profeesor- endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
+98 41 1335 7850
Email
mobasserimajid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Mobaseri
Position
Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
+98 41 1335 7850
Email
mobasserimajid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr.Shahram Ghiyasvand
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
ghiyasvand@live.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)