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Effects of high-protein and balance diets on fasting blood glucose,weight loss, body composition and adiponectin levels in obese and overweight women at aerobic clubs

Protocol summary

Summary
objective: determination and comparison effect of high-protein and balanced diets on fasting blood glucose, weight loss, body composition and adiponectin levels in obese and overweight women at aerobic clubs. exclusion criteria: patients with metabolic diseases such as cardiovascular diseases, hypertentin, glocose intolarate, diabetic, pregnancy are not included in the study. Inclusion criteria: filled testimonial, aged between 20-46, BMI more than 25, dont take supplement,dont be on diet for weight loss during 6 months ago, dont have disease. 60 indiviuals who were eligible will adhere specific diet( we randomizely will set individuals in high protein( 45% carbohydrate, 25% protein, 30%fat) and balanced diets(55% carbohydrate, 15% protein, 30%fat) for 8 weeks and do aerobic three times with duration 60 minutes. for assessing diet 3-day records will use. we will bleed 10 cc for measuring adiponectin, fasting blood glocose, by standard kits and also weight and height( Height will be measured by stadiometer with 0.5 cm precision in normal standing position and weight by seca with 0.5 kg precision).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402245062N7
Registration date: 2014-06-26, 1393/04/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-26, 1393/04/05
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-15, 1391/09/25
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of high-protein and balance diets on fasting blood glucose,weight loss, body composition and adiponectin levels in obese and overweight women at aerobic clubs
Public title
effect of high protein diet and balance diet in obese and overweight women at aerobic clubs
Purpose
Prevention
Inclusion/Exclusion criteria
exclusion criteria: patients with metabolic diseases such as cardiovascular diseases, hypertentin, glocose intolarate, diabetic, pregnancy are not included in the study. Inclusion criteria:filled testimonial, aged between 20-46,BMI more than 25,dont take supplement, dont be on diet for weight loss during 6 months ago, dont have renal, hepatic,diabet disease,smoking
Age
From 20 years old to 46 years old
Gender
Female
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
81745319
Approval date
2013-06-12, 1392/03/22
Ethics committee reference number
392233

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
weight
Timepoint
at baseline and after 8 weeks
Method of measurement
seca scale

2

Description
fasting blood glocose
Timepoint
at baseline and 8 weeks after intervention
Method of measurement
Colorimetry

3

Description
adiponectin
Timepoint
at baseline and after 8 weeks intervention
Method of measurement
Enzymatic assay with autoanalyser

4

Description
percent of body fat mass
Timepoint
at baseline and after 8 weeks intervention
Method of measurement
caliper

5

Description
percent of fat free mass
Timepoint
at baseline and after 8 weeks intervention
Method of measurement
caliper

Secondary outcomes

1

Description
BMI
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
calculation

Intervention groups

1

Description
high protein (45%carbohydrate,25%protein,30%fat) for 8 weeks. daily energy calculated by harisbenedict and 500 cal lower than amount of calculated
Category
Other

2

Description
balanced diet (55%carbohydrate,15%protein,30%fat) for 8 weeks. daily energy calculated by harisbenedict and 500 cal lower than amount of calculated
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The amniation and research center, Isfahan University of Medical Sciences.
Full name of responsible person
Doctor Reza Ghiasvand
Street address
Department of Community Nutrition, School of Nutrition and Food sciences, Isfahan University of Medical Sciences, Hezar jerib street.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The endocrine and metabolism reaserch center, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Askari
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The endocrine and metabolism reaserch center, 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
Pegah Amini
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+31 17752091
Fax
Email
pegah4444@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Doctor Reza Ghiasvand
Position
Ph.D of nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
03117922742
Phone
+31 17922742
Fax
Email
ghiasvand@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
Pegah Amini
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
03117752091
Phone
+31 17752091
Fax
Email
pegah4444@yahoo.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
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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