Protocol summary

Summary
Honey vinegar syrup contains of Vinegar and honey. It can affect blood sugar, blood fat and weight effectively and since earlier studies have not been done in this direction, so the present study will investigate the effect of honey vinegar syrup on weight, glucose and lipid parameters. Sixty healthy adults will be included in the study. After completing consent forms, subjects will be randomly assigned to either intervention (receiving normal diet plus honey vinegar syrup) or control (receiving normal diet) groups. Inclusion criteria: absence of acute or chronic disease, not pregnant or breastfeeding, aged between 20 to 40 years and body mass index between 18.5 and 30. Exclusion criteria: allergy to vinegar, honey or honey vinegar syrup. Demographic information and laboratory results will be designed for each subject, before and after intervention. Dietary measurements will be performed by using 3 days food records. Subjects will be received normal diet (control) or a normal diet plus honey vinegar syrup (intervention) once a day for 4 weeks. We will call or text subjects once a week to remind them to take the honey vinegar syrup regularly. An expert dietitian will keep in touch with subjects to solve any problems if there is some. Biochemical parameters including Fasting Blood Sugar, Serum Insulin Level, Lipid profiles, also anthropometric indices such as weight, height, waist circumference and hip circumference will be assessed at the beginning and the end of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020816529N1
Registration date: 2014-04-17, 1393/01/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-17, 1393/01/28
Registrant information
Name
Mohammad hassan Entezari
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8487
Email address
entezari@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Isfahan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of honey vinegar syrup along with a normal diet compared with normal diet alone on glycemic status and insulin resistance, lipid profiles and weight changes in healthy subjects
Public title
effect of honey vinegar syrup on healthy subjects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: absence of chronic heart, kidney, liver or lung diseases, chronic or acute inflammatory diseases (including acute inflammation of the pancreas, and endocarditis), thyroid dysfunction, heart valve disease, aged between 20 to 40 years, not pregnant or breastfeeding, body mass index between 18.5 and 30, no smoking, not use of fat or blood glucose lowering drugs, or medications affecting appetite at least the previous 6 months, lack of allergy to vinegar, honey or honey vinegar syrup. Exclusion criteria: lack of cooperation in the study or catching an acute illness.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, after the selection of eligible individuals, based on a random draw and randomized allocation, individuals will divided into either intervention or control group.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Approval date
2013-10-28, 1392/08/06
Ethics committee reference number
392437

Health conditions studied

1

Description of health condition studied
healthy subjects
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fasting Blood Glucose
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Colorimetry

2

Description
Serum Insulin
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)، µU/mL

3

Description
Total serum cholesterol
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Enzymatic assay with autoanalyser

4

Description
Serum triglycerides
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Enzymatic assay with autoanalyser

5

Description
BMI
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Formula

6

Description
Serum High density lipoprotein
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Enzymatic assay with autoanalyser

7

Description
Serum low density lipoprotein
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Enzymatic assay with autoanalyser

8

Description
WHR
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Formula

9

Description
HOMA-IR
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Formula

10

Description
Weight
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Scale, Kilogram

Secondary outcomes

1

Description
Blood pressure
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
mmHg, sphygmomanometer

2

Description
Height
Timepoint
The first day of the study
Method of measurement
Meter, Centimeter

3

Description
Waist Circumference
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
meter, centimeter

4

Description
Hip Circumference
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
meter, centimeter

5

Description
Skinfold thickness
Timepoint
The first day of the study and the last day of 4th week
Method of measurement
Caliper, mm

Intervention groups

1

Description
normal diet plus honey vinegar syrup, honey vinegar contains of 1000 grams honey and 300 grams vinegar, two tablespoons of honey vinegar with a glass of water, once a day for a month
Category
Prevention

2

Description
normal diet
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Esfahanian healthy adults
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman. Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
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, Isfahan 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
Isfahan university of medical sciences
Full name of responsible person
Seyedeh Masumeh Derakhshandeh Rishehri
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Iran
Phone
+98 31 1661 6342
Fax
Email
ma.derakhshandeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Dr. Mohammad Hassan Entezari
Position
Ph.D of nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Iran
Phone
+98 31 1792 2752
Fax
Email
entezari@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Seyedeh Masumeh Derakhshandeh Rishehri
Position
MSc Student of Nutrition
Other areas of specialty/work
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Iran
Phone
+98 31 1661 6342
Fax
Email
ma.derakhshandeh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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