Current study investigates the effect of consumption of 6 meals per day in comparison to regular diet in people with overweight.The patients should be BMI>25 and not being case of kidney, liver and cardiovascular diseases. The individuals in case group consume their diets in 6 isocaloric meals per day. After 3 month, case group serum will compare with control group for the following factors:weight, TG, total cholesterol, LDL, HDL,leptin and adiponectin.
General information
Acronym
body mass index
IRCT registration information
IRCT registration number:IRCT2012102911307N1
Registration date:2012-12-11, 1391/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-11, 1391/09/21
Registrant information
Name
Zeynab Hatami Zargaran
Name of organization / entity
Health and Nnutrition School, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1002
Email address
hatamiz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation of the effects of frequent meal on weight, lipid profile,leptin and adiponectin in overweight people
Public title
Effect of meal frequency (6 equal meals) on weight and blood lipid in overweight people
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: BMI> 25 and age between 20 to 65 years. Exclusion criteria: no history of chronic diseases (cancer, kidney disease, liver disease and heart failure); No being under special circumstances such as pregnancy; do not have night shift work and not taking weight reduction medications.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
zand street
City
shiraz
Postal code
Approval date
2012-08-16, 1391/05/26
Ethics committee reference number
CT-916203
Health conditions studied
1
Description of health condition studied
overweight people
ICD-10 code
E-66
ICD-10 code description
obesity
Primary outcomes
1
Description
weight
Timepoint
befor the interventio, 3 month after the intervention
Method of measurement
seca scale
2
Description
lipid profile
Timepoint
befor the interventio, 3 month after the intervention
Method of measurement
biosystem autoanalyzer bt1500
3
Description
leptin
Timepoint
befor the interventio, 3 month after the intervention
Method of measurement
ELISA
4
Description
adiponectin
Timepoint
befor the interventio, 3 month after the intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
A diet with 6 isocaloric meal was designed for the intervention group. 500 kcal is subtracted from energy requirement for weight maintenance
Category
Lifestyle
2
Description
control group: 500 kcal is subtracted from energy requirement for weight maintenance.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Leadership Institute of Medical Sciences, Shiraz
Full name of responsible person
fateme hatami
Street address
mollasadra street,lane 29,Academy of Medical Sciences
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmoddini
Street address
Vice-Chancellery of Research and Technology,store 7th, Shiraz University of Medical Science Centeral Bulding, beside Helale-Ahmar, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology, Shiraz 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
Health and Nutrition School, Shiraz University of Medical Sciences