The aim of this study is evaluation the effect of apple vinegar tablets on metabolic syndrome and its components in 20 to 60 years old patients with metabolic syndrome. Pregnant and lactating women, drug addicts and people with underlying disease will be excluded. 120 people will be randomly divided into two groups: 60 in apple cider vinegar tablets group and 60 in placebo group. Tablets will be consumed twice a day, after lunch and dinner for three months. Factors affecting the metabolic syndrome, including type and amount of diet and physical activity will be at the same level. Based on ATPIII criteria three or more of the following criteria is enough for diagnosis of metabolic syndrome in the Middle East:
Central obesity (Waist circumference in men> cm94 and women> cm80)
hypertriglyceridemia: (TG> mg/dl 150 or treated with anti-lipid)
Low levels of HDL-C: Men <mg/dl 40 and in women <mg/dl 50 or treated with anti-lipid)
Hypertension: systolic blood pressure>130 or diastolic>85 or antihypertensive therapy)
High blood glucose>mg/dl 100 or by treatment with a previous diagnosis of DM2
All diagnostic criteria intervention in both groups before and after the intervention will be measured and recorded. Finally, the two groups will be compared.
General information
Acronym
ACV , apple cider vinegar
IRCT registration information
IRCT registration number:IRCT2015051222232N1
Registration date:2015-06-02, 1394/03/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Marzieh Peyravi Dehsorkhi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2006
Email address
h.doustkami@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of apple cider vinegar tablets on metabolic syndrome and its components in patients with metabolic syndrome
Public title
The effect of apple cider vinegar tablets on metabolic syndrome and its components in patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with metabolic syndrome twenty to sixty years old
Exclusion criteria: Pregnant patients; nursing mothers; smokers; consumers of alcohol; drugs; patients with type I diabetes; significant impairment of renal function; thyroid disorders; liver disorders; acute and chronic inflammatory diseases; lack of mobility; recent surgery; myocardial infarction; any cerebrovascular accident in the last quarter
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah st., Ardabil,
City
Ardabil
Postal code
56189985991
Approval date
2014-10-18, 1393/07/26
Ethics committee reference number
arums.ric.93.50
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
high blood pressure
2
Description of health condition studied
Central obesity
ICD-10 code
E65
ICD-10 code description
Localized adiposity
3
Description of health condition studied
High density lipoprotein deficiency
ICD-10 code
E78.6
ICD-10 code description
High density lipoprotein deficiency
4
Description of health condition studied
hypertriglyceridaemia
ICD-10 code
E78.1
ICD-10 code description
hypertriglyceridaemia
5
Description of health condition studied
High blood Glucose
ICD-10 code
R73.9
ICD-10 code description
Hyperglycemia, unspecified
Primary outcomes
1
Description
Metabolic syndrome
Timepoint
Before the intervention and after three months of intervention
Method of measurement
According to criteria of ATPIII three or more of the following criteria for diagnosis of metabolic syndrome is in the Middle East: Central obesity (waist circumference in men> cm 94 in women> cm 80) hypertriglyceridemia (TG> mg / dl 150 or anti-lipid therapy), low levels of HDL-C: Men <mg / dl 40 and in women <mg / dl 50 or anti-lipid therapy) hypertension (systolic blood pressure> 130 or diastolic> 85 or under antihypertensive treatment), high blood sugar> mg / dl 100 or by treatment with a previous diagnosis DM2
Secondary outcomes
1
Description
FBS
Timepoint
Before the intervention and three months after intervention
Method of measurement
In milligrams per deciliter of blood samples will be measured by standard devices; BT-3500 made in Italy and OLYMPUS AU400 models made in Japan
2
Description
triglyceride
Timepoint
Before the intervention and three months after intervention
Method of measurement
In milligrams per deciliter of blood samples will be measured by standard devices; BT-3500 made in Italy and OLYMPUS AU400 models made in Japan
3
Description
high density lipoprotein- Cholesterol
Timepoint
Before the intervention and three months after intervention
Method of measurement
In milligrams per deciliter of blood samples will be measured by standard devices; BT-3500 made in Italy and OLYMPUS AU400 models made in Japan
4
Description
waist circumference
Timepoint
Before the intervention and three months after intervention
Method of measurement
In cm by means of meters and when standing at the level of the umbilicus (between vertebrae L4 and L5) is measured.
5
Description
Blood pressure
Timepoint
Before the intervention and three months after intervention
Method of measurement
Will be in millimeters of mercury. Mercury barometer by Richter and by calculating the average of 3 times measured in a sitting position and after ten minutes of rest will be measured. Diastolic blood pressure was measured using the fifth korotokof sound.
Intervention groups
1
Description
Intervention group of apple cider vinegar tablets containing 400 to 500 milligrams of active ingredient of apple vinegar Manufactured with American Bronson company twice a day after lunch and dinner will be given for three months.
Category
Treatment - Drugs
2
Description
The control group received placebo pills (placebo) with the same dimensions of the original drug (apple vinegar tablets) will be. And will have no pharmacological effect. Twice a day, immediately after lunch and dinner and will be given a period of three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The office of the doctor, Mahmoud Parham
Full name of responsible person
Dr. Mahmoud Parham, Professor of Endocrinology and Metabolism, faculty member Qom University
Street address
Qom, 45-meter street Saduq Street Shahbazi, Medical Building, third floor, the office of the doctor Parham
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Miss parvane naftchi
Street address
Ardabil University of Medical Sciences, Daneshgah st., Ardabil,
City
Ardabi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Hossein Doustkami
Position
Cardiology, Interventional Fellowship, a member of the faculty of Ardabil University of medical scie
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Daneshgah st., Ardabil,
City
Ardabil
Postal code
5618985991
Phone
+98 45 3351 2006
Fax
+98 45 3351 8939
Email
h.doustkami@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Hosein Doustkami
Position
Cardiology, Interventional Fellowship, a member of the faculty of Ardabil University of medical scie
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Daneshgah st., Ardabil,
City
Ardabil
Postal code
5618985991
Phone
+98 45 3351 2006
Fax
+98 45 3351 8939
Email
h.doustkami@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Hossein Doustkami
Position
Cardiology, Interventional Fellowship, a member of the faculty of Ardabil University of medical scie
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Daneshgah st., Ardabil,
City
Ardabil
Postal code
5618985991
Phone
+98 45 3351 2006
Fax
+98 45 3351 8939
Email
h.doustkami@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)