Comparison of the effects of cow milk, fortified soy milk, and calcium supplement on anthropometric indices, adipocytokins, blood pressure, and insulin resistance in premenopaused over weight and obese women
In this clinical trial, 100 healthy overweight or obese premenopausal women were randomized to one of the following dietary regimens for 8 weeks: (1) a control diet providing a 500 kcal/day deficit, with 500-600 mg/day dietary calcium; (2) a calcium-supplemented diet identical to the control diet with 800 mg/day of calcium as calcium carbonate; (3) a milk diet providing a 500 kcal/day deficit and containing three servings of low-fat milk; (4) a soy milk diet providing a 500 kcal/day deficit and containing three servings of calcium fortified soy milk. At baseline and after 8 weeks, weight, waist circumference, and hip circumference were measured. Three 24-h dietary records and physical activity records were also taken.
General information
Acronym
Effect of calcium and milk on weight loss and insulin resistance
IRCT registration information
IRCT registration number:IRCT2013042113080N1
Registration date:2013-05-13, 1392/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-13, 1392/02/23
Registrant information
Name
Shiva Faghih
Name of organization / entity
Shiraz University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
sh_faghih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of Nutrition and Food Technology Research
Expected recruitment start date
2009-01-19, 1387/10/30
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of cow milk, fortified soy milk, and calcium supplement on anthropometric indices, adipocytokins, blood pressure, and insulin resistance in premenopaused over weight and obese women
Public title
Effect of calcium and dairy product on weight loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were as follows: body mass index (BMI) more than 25 kg/m2 (range 25-40); taking no medications or supplements which might affect
metabolism of calcium, vitamin D or weight loss; absence of menopause; stable body weight (body weight change less than 3 kg for the last 2 months); absence of coronary-artery disease, diabetes, hypertension, thyroid, and kidney diseases. The subjects were not pregnant and non-lactating with no allergy to milk or soy milk and were not lactose intolerance.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institute of nutrition and food technology research
Street address
farahzad- arghavan- school of nutrition
City
tehran
Postal code
Approval date
2009-01-03, 1387/10/14
Ethics committee reference number
024342
Health conditions studied
1
Description of health condition studied
overweight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
weight
Timepoint
2 month
Method of measurement
scale
Secondary outcomes
1
Description
lipid prophile
Timepoint
2 month
Method of measurement
serum lipids
2
Description
insulin resistance
Timepoint
2 month
Method of measurement
HOMA-IR
Intervention groups
1
Description
(a) a control diet which has 500-kcal/day reduction in energy.
Category
Other
2
Description
a calcium-supplemented diet containing 800 mg/day calcium carbonate and 500kcal/day energy reduction
Category
Treatment - Drugs
3
Description
a high-milk diet containing three servings of low-fat milk and 500kcal/day energy reduction
Category
Treatment - Drugs
4
Description
a soy-milk diet containing three servings of calcium-fortified soy milk and -500kcal/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nutrition- Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute of Nutrition and Food Technology Research
Full name of responsible person
Dr Hedayat Hoseini
Street address
Farahzad- Arghavan
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute of Nutrition and Food Technology Research
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 University of Medical Sciences
Full name of responsible person
Shiva Faghih
Position
Assisstant professor
Other areas of specialty/work
Street address
Razi boulevard
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
sh_faghih@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiva Faghih
Position
PhD
Other areas of specialty/work
Street address
Razi boulevard
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
sh_faghih@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiva Faghih
Position
PhD
Other areas of specialty/work
Street address
school of health and nutrition- razi boulevard
City
shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
sh_faghih@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)