Effect of honey consumption on the lipid profile, blood pressure, and serum levels of adiponectin and C-reactive protein in patients with type 2 diabetes
The purpose of this study is determination of the effect of honey consumption on glycemic control and oxidant and antioxidant compounds in patients with type 2 diabetes. The study is cross-sectional with two groups, the intervention group that will receive honey and a control group. The sample size is 50 in each group. Participants are patients with type 2 diabetes with fasting blood sugar < 200 mg/dl. Participants should be non-insulin dependent without a critical medical condition or infectious disease. Hospitalization or involvement in serious diseases will exclude patients from the study. The participants will be asked not to change their diet, life style, and physical activity during the study. In the first sequence of the study, one group will receive honey (50 g/day) for 8 weeks while the control group will be left without any intervention. Then a 4-week wash-out period will be established in which both of the groups do not consume honey. After the wash-out period, the second sequence of study will start and the role of groups will interchange. Both groups will be on weight-maintenance diet throughout the study. At the beginning and end of each sequence of study, blood samples will be collected to assess the changes (lipid profile, serum adiponectin and c-reactive protein).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062122364N2
Registration date:2015-08-04, 1394/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
Fateme Sadeghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3640 7221
Email address
f_sadeghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-14, 1394/01/25
Expected recruitment end date
2015-09-16, 1394/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of honey consumption on the lipid profile, blood pressure, and serum levels of adiponectin and C-reactive protein in patients with type 2 diabetes
Public title
Effect of honey on type 2 diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: type II diabetic patient with a fasting blood sugar less than 200 milligrams per deciliter; free of a history or presence of malignancy; acute and emergency states; a history of major operations; a drug history of Immunomodulators, cytotoxic or immunosuppressive agents; no pregnancy or lactation if female; and not using insulin for diabetes control. Exclusion criteria: Participants will exclude in the case of any kind of acute diseases; hospitalization or meet the criteria mentioned in Inclusion criteria.
Age
From 35 years old to 75 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Siraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Postal code
7134814336
Approval date
2015-03-08, 1393/12/17
Ethics committee reference number
CT-P-9386-8456
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
adiponectin
Timepoint
Baseline, 8 weeks after baseline, the end of the washout period, 8 weeks after the start of the second period
Method of measurement
ELISA
2
Description
C-reactive protein
Timepoint
Baseline, 8 weeks after baseline, the end of the washout period, 8 weeks after the start of the second period
Method of measurement
ELISA
Secondary outcomes
1
Description
Total cholestrol
Timepoint
Baseline, 8 weeks after baseline, the end of the washout period , 8 weeks after the start of the second period of study
Method of measurement
Pars Azmun Kit
2
Description
triglyceride
Timepoint
Baseline, 8 weeks after baseline, the end of the washout period , 8 weeks after the start of the second period of study
Method of measurement
Pars Azmun Kit
3
Description
LDL cholestrol
Timepoint
Baseline, 8 weeks after baseline, the end of the washout period , 8 weeks after the start of the second period of study
Method of measurement
Pars Azmun Kit
4
Description
HDL cholestrol
Timepoint
Baseline, 8 weeks after baseline, the end of the washout period , 8 weeks after the start of the second period of study
Method of measurement
Pars Azmun Kit
5
Description
blood pressure
Timepoint
Baseline, 4 weeks after baseline, 8 weeks after baseline, the end of the washout period, 4 weeks after the start of the second period of study , 8 weeks after the start of the second period of study
Method of measurement
mercury manometer
Intervention groups
1
Description
The intervention group consume Astragalus honey ( 50 grams per day) three times between meals for 8 weeks.After wash out period(4 weeks) , they will not consume honey(8 weeks.)
Category
Other
2
Description
Control group do not consume honey.After wash out period, they will consume honey for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmad Nader Kazemi clinic
Full name of responsible person
Dr. Mohamad Marzughi
Street address
Valiasr square, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Science
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Central Building of Shiraz University of Medical Science , Zand Ave
City
Shiraz
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 of Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Dr Masoume Akhlaghi
Position
PhD in Nutrition Sciences/Faculty member
Other areas of specialty/work
Street address
Faculty of Food Science and Nutrition, Razi Blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Masoume Akhlaghi
Position
ّّPhD in Nutrition Sciences/Faculty member
Other areas of specialty/work
Street address
Faculty of Food Science and Nutrition, Razi Blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Scienceّ
Full name of responsible person
ّّFateme sadeghi
Position
Postgraduate student
Other areas of specialty/work
Street address
Faculty of Food Science and Nutrition, Razi Blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
f.sadeghi6821@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)