Evaluation the effect of apple cider vinegar on glycemic index and lipid profile in patients with type 2 diabetes
Design
Randomized clinical trial with parallel groups, not blinding, with control group
Settings and conduct
The target group is patients with type 2 diabetes that will be selected from patients visited in Golestan hospital in Ahvaz city and will be randomly divided into two intervention and control groups. Apple cider vinegar is the treatment and subjects will be followed for 8 weeks. Blood samples will be taken before and after the intervention period and the outcome variables will be measured between two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic patients with hyperlipidemia which only statin
has been administrated for them, non-use of nutritional supplements, non-use of cider routinely or daily during 3 last months, non-insulin injection, body mass index between 18.5-34.9. Exclusion criteria: Renal and digestive diseases, pregnancy and lactation, insulin injection.
Intervention groups
Intervention group: apple cider vinegar with energy controlled diet based on the subject's need. Control group: energy controlled diet based on the subject's need
Main outcome variables
Fasting blood glucose, triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol, Hemoglobin A1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140107016123N13
Registration date:2018-11-05, 1397/08/14
Registration timing:prospective
Last update:2018-11-05, 1397/08/14
Update count:0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of apple cider vinegar on glycemic index and lipid profile in patients with type 2 diabetes
Public title
Effect of apple cider vinegar on treatment of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hyperlipidemic-diabetic patients with only statin administration
Non-use of nutritional supplements
Non-daily consumption of cider during last 3 months
Non-insulin injection
Body mass index between 18.5 to 34.9
Age ranges between 30 to 60 years
The willingness to participate in the study
Exclusion criteria:
Existing renal diseases
Body mass index more than 35
Pregnancy and lactation
Insulin injection
Patients with gastric disorders such as reflex and gastric ulcer
Smoking more than one cigarettes a day
Existing cancer
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.AJUMS.REC.1397.476
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before and after intervention
Method of measurement
Enzymatic colorimetric
2
Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Enzymatic colorimetric
3
Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Enzymatic colorimetric
4
Description
High density lipoprotein-cholesterol
Timepoint
Before and after intervention
Method of measurement
Enzymatic colorimetric
5
Description
low density lipoprotein-cholesterol
Timepoint
Before and after intervention
Method of measurement
Friedewald Equation
6
Description
Hemoglobin A1c
Timepoint
Before and after intervention
Method of measurement
Enzymatic colorimetric
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive apple cider vinegar with energy controlled diet based on the subject's need, for 8 weeks.
Category
Treatment - Other
2
Description
Control group will receive energy controlled diet based on the subject's need, for 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
sjafarirad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Elahi
Position
Master of Sciences student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
Mr.elahi.2003@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
sjafarirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammadreza Elahi
Position
Master of Sciences student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
Mr.elahi.2003@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available