Comparison effects of industrial and traditional honeys on blood glucose levels and its correlation with sucrose tests of honey (randomized clinical trial)
Determining the effects of different types honeys on blood sugar and comparing with laboratory analysis of honey
Design
Clinical trial with 5 intervention group, on 90 patients diabetics, with parallel groups, with one control group, blinded, randomized based on random number table of Krejcie & Morgan. Finally, SPSS software was used for data analysis.
Settings and conduct
The study will be performed in Imam Reza (AS) Clinic in Arak and is double-blind. The intervention group includes diabetic patients receiving traditional honey, industrial honey and fructose syrup (equivalent to 50 grams of dietary carbohydrates) consume fasting. First, fasting blood sugar is measured. Then the participants' blood sugar will be tested again after half an hour.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1)Diabetic patients with fast blood sugar greater than 110 mg/dL
Exclusion criteria:
1)Pregnant and breastfeeding women
2)Patients with history of major surgery, or underlying disease, including cardiovascular, infectious
3)Non-insulin-dependent diabetes mellitus
Intervention groups
Intervention group include 5 groups: diabetic patients that receiving traditional honey, receiving 3 brand of different industrial honey and receiving fructose syrup. Each group consumes equivalent 50 grams of dietary carbohydrates in the form of soluble substance. The control group also includes patients receiving drinking water.
Main outcome variables
Blood glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210125050135N1
Registration date:2022-04-09, 1401/01/20
Registration timing:registered_while_recruiting
Last update:2022-04-09, 1401/01/20
Update count:0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
Mohaddeseh Asafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 5573
Email address
m.asafari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of industrial and traditional honeys on blood glucose levels and its correlation with sucrose tests of honey (randomized clinical trial)
Public title
Comparison the effect of industrial and traditional honeys on blood glucose levels in diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Fast blood sugar upper 110 mg/dl
Exclusion criteria:
Pregnant and breastfeeding women
Patients with history of major surgery, or underlying disease, including cardiovascular and infectious
Non-insulin dependent diabetes mellitus
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
Fasting blood samples and post-consumption, blood samples
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers and patients will not know whether they are in the control or intervention group. In this way, industrial, traditional honeys, fructose syrup and drinking water are prepared by a person (out-of-study,in a room away from the eyes of clinical caregivers and patients) in equal amounts in similar glasses as soluble and then coded, that only he is known from the contents of the dishes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.ARAKMU.REC.1399.291
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fast Blood Sugar (FBS)
Timepoint
FBS is measured at the beginning of study, then 30 minutes after consumption of honey will be measured again.
Method of measurement
Digital blood glucose testing device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Diabetic patients receiving traditional honey (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)
Category
Diagnosis
2
Description
Intervention group 2: Diabetic patients receiving industrial honey (produced in Khomeyn Honey's Ferdows factory, with thr Giti Sabz Khomeyn brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)
Category
Diagnosis
3
Description
Intervention group 3: Diabetic patients receiving industrial honey (produced in Khomeyn Honey's Salar factory, with the Salar brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)
Category
Diagnosis
4
Description
Intervention group 4: Diabetic patients receiving industrial honey (produced in Shahram Nabavi's factory, with the Teymareh brand), (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)
Category
Diagnosis
5
Description
Intervention group 5: Diabetic patients receiving fructose syrup (produced in Zar Industrial and Research Group, with the Zar brand) (equivalent to 50 grams of carbohydrates consumed in the diet, once, fasting)
Category
Diagnosis
6
Description
Control group: Patients receiving drinking water (130 cc, once, fasting)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza (AS)
Full name of responsible person
Bahman Sadeghi
Street address
Abbas Abad, Shahid Shirodi
City
Arak
Province
Markazi
Postal code
3813899589
Phone
+98 86 3402 0030
Email
drbhs59176@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Abbas Alimoradian
Street address
Arak, Golestan District - Deputy of Food and Drug Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3818653366
Phone
+98 86 3368 5570
Email
ab_alimoradian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Abbas Alimoradian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Arak, Golestan District - Deputy of Food and Drug Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3818653366
Phone
+98 86 3367 8626
Email
ab_alimoradian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Abbas Alimoradian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Arak, Golestan District - Deputy of Food and Drug
City
Arak
Province
Markazi
Postal code
3818653366
Phone
+98 86 3368 5570
Email
ab_alimoradian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohaddeseh Asafari
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Arak, Golestan District - Deputy of Food and Drug
City
Arak
Province
Markazi
Postal code
3818653366
Phone
+98 86 3368 5570
Email
m.asafari.132@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information will be published in the final report and article.
When the data will become available and for how long
The information will be published in the final report and article.
To whom data/document is available
The information will be published in the final report and article.
Under which criteria data/document could be used
The information will be published in the final report and article.
From where data/document is obtainable
The information will be published in the final report and article.
What processes are involved for a request to access data/document
The information will be published in the final report and article. If they need more information, they can send an email to responsible author.