This Randomized Controlled study is accomplished to control weight , improve lipid profile and reduce blood pressure in 75 premenoposal overweight or obese women by milk and kefir drink replacement in diet for 2 months and it's effect on anthropometric Indises , lipid profile and Blood Pressure. Particioants will be randomly devided into milk , kefir drink and control groups. Energy requirement for each person will be stimated by EER formula and the macronutrients percentage are equal for 3 groups.The milk and kefir groups consume 2 more servings of dairy products than the control group.The factors which are named above, will be measured at the beginning and at the end of the sudy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061313661N1
Registration date:2014-03-09, 1392/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-09, 1392/12/18
Registrant information
Name
Yasamin Fathi
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1843 5616
Email address
fathiy@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-22, 1393/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects Of Milk and Kefir Drink Consumption On Anthropometric Indises ,Lipid Profile and Blood Pressure In Premenoposal or Obese women
Public title
Comparision Of The Effects Of Milk and Kefir Drink Consumption On Anthropometric Indises ,Lipid Profile and Blood Pressure In Premenoposal or Obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: female sex ; age over 25 ; BMI over 25 ; agreed with lactose and mlik ; not be menopause ; not be pregnant, not lactating, not using any drugs and nutritional supplement ; not participate in other trials over the last 6 months ; not having any disease such as thyroid ,diabetes. hypertension
Exclusion Criteria : Don"t want to fallow the trial
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Shiraz Medical University
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Shiraz Medical University
Street address
Olumpezeshki Department, Zand Street, Shiraz, Fars
City
Shiraz
Postal code
Approval date
2013-11-29, 1392/09/08
Ethics committee reference number
1392-6751
Health conditions studied
1
Description of health condition studied
Overweight or Obese
ICD-10 code
E66
ICD-10 code description
Obesity
Primary outcomes
1
Description
Weight
Timepoint
At the beginning and at the end of the study
Method of measurement
Bascul-e- Sahand Set(with 100 grams accuracy)
2
Description
Lipid profile
Timepoint
At the beginning and at the end of the story
Method of measurement
By use of bt 1500 set and pars test kit
3
Description
Waist Circumference
Timepoint
At the beginning and at the end of the study
Method of measurement
Tape measure
4
Description
Blood pressure
Timepoint
At the beginnig and at the end f the study
Method of measurement
mmgh-piezometer
Secondary outcomes
1
Description
BMI
Timepoint
At the beginning and at the end of the study
Method of measurement
weight (kg) divided by square of height (m)
Intervention groups
1
Description
Estimation of daily energy for each person by EER Formula
Daily consumption of 500 cc milk for 2 months which it's energy and macronutrients has been calculated
Category
Lifestyle
2
Description
Estimation Of Daily Energy for each person by EER Formula
Daily Consumption of 750 cc kefir for 2 months which it's energy and macronutrients has been calculated.
Category
Lifestyle
3
Description
Estimation of Daily Enrgy by EER Formula
Go on a diet contained 2 servings of dairy pruducts( 2servings less than intervention groups)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center
Full name of responsible person
Yasamin Fathi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Medical University
Full name of responsible person
Dr Gholamreza Hatam
Street address
Shiraz, Zand Street, Olumpezeshki Department, The 7th Floor
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Medical University
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
Shiraz Medical University, Nutrition College
Full name of responsible person
Yasamin Fathi
Position
Msc of Nutrition
Other areas of specialty/work
Street address
kooy-e-Zahra Street,Fatholmobin Alley,Nutrion College
City
Shiraz
Postal code
Phone
+98 71 1843 5616
Fax
Email
yasaminfathi@ymail.comfathiy@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University, Shiraz,Fras
Full name of responsible person
Dr Shiva Faghih
Position
phd of nutrition
Other areas of specialty/work
Street address
kooy-e-Zahra Street,Fatholmobin Alley,Nutrition College
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
shivafaghih@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical University, Shiraz, Fars
Full name of responsible person
Yasamin Fathi
Position
Msc Of Nutrition
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)