Protocol summary

Summary
Obesity and overweight are increasing because of increased incidence of many diseases such as coronary heart disease. The effect of heat shock proteins in cardiovascular disease has been confirmed. Therefore, simple check-off treatments like acupuncture treatment of obesity while reducing cardiovascular risk factors is important. Participants, male and female aged between 16 to 60, BMI>25, without drug history and Heart disease, (n=550), were randomized to therapeutic body acupuncture, auricular acupuncture, sham groups (sham body and auricular acupuncture) and control group just with low calorie diet. Subjects received authentic (cases) or sham acupuncture and control for 6-weeks (first-period) in combination with a low-calorie diet. In the next 6-week (second-period), the low-calorie diet was used on its own. Subjects were assessed at the beginning, 6 and 12 weeks later. In addition to anthropometric and lipid parameters, serum anti-heat shock protein (Hsp)-27, 60, 65, 70 and high sensitive C-reactive protein (hs-CRP) levels were assessed.

General information

Acronym
Effect of Acupuncture on body weight and antibody titers against Heat Shock Protein
IRCT registration information
IRCT registration number: IRCT201201127117N2
Registration date: 2012-01-17, 1390/10/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-17, 1390/10/27
Registrant information
Name
Majid Ghayour Mobarhan
Name of organization / entity
Mashhad University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 51 1822 8573
Email address
ghayourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Acupuncture on body weight and antibody titers against Heat Shock Protein, 27, 60, 65 and 70 in Iranian obese
Public title
Effect of Acupuncture on body weight and antibody titers against Heat Shock Protein, 27, 60, 65 and 70 in Iranian obese
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects are eligible if they are completely healthy; male and female subjects; age between 16 to 60; BMI>25 and no medical or drug history Exclusion criteria: Diabetes; sever hypertension; Heart disease (CHD, MI, Bypass); Pregnancy and age below 18 and above 60 years
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 550
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
86058

Health conditions studied

1

Description of health condition studied
obesity and overweight
ICD-10 code
E66.9
ICD-10 code description

Primary outcomes

1

Description
Weight
Timepoint
Before threatment. 1/5 month after threatment and 1/5 month after stoping the threatment
Method of measurement
Bioimpedanses

2

Description
Body mass index
Timepoint
Before threatment. 1/5 month after threatment and 1/5 month after stoping the threatment
Method of measurement
Bioimpedanses

3

Description
Waist and hip circumference
Timepoint
Before threatment. 1/5 month after threatment and 1/5 month after stoping the threatment
Method of measurement
Meter

Secondary outcomes

1

Description
Biochemistry factors
Timepoint
Before intervention, 1.5 month after and 1.5 month after the end of treatment
Method of measurement
Auto analyser

2

Description
Heat Shock Protein 27,60, 65 and 70
Timepoint
Before intervention, 1.5 month after and 1.5 month after the end of treatment
Method of measurement
ELISA

Intervention groups

1

Description
110 obese people with low calorie diet
Category
Other

2

Description
110 obese peaple with low calorie diet + body acupuncture
Category
Treatment - Drugs

3

Description
110 obese people with low calorie diet + sham body acupuncture
Category
Placebo

4

Description
110 obese people with low calorie diet + auricular acupuncture
Category
Treatment - Drugs

5

Description
110 obese people with low calorie diet + sham auricular acupuncture
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition clinic, Ghaem hospital, Mashhad.
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
jalil tavakol afshar
Street address
Park squer- Medical university
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Position
MD
Other areas of specialty/work
Street address
Park squer- Medical University
City
Mashhad
Postal code
Phone
+98 51 1882 8573
Fax
Email
ghayourm@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Position
MD
Other areas of specialty/work
Street address
Park squer
City
Mashhad
Postal code
Phone
+98 51 1882 8573
Fax
Email
ghayourm@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Position
MD
Other areas of specialty/work
Street address
Medical university, Park sque.
City
Mashhad
Postal code
Phone
Fax
Email
ghayourm@mums.ac.ir
Web page address

Sharing plan

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