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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01253876
Other study ID # Soy milk weight blood pressure
Secondary ID
Status Completed
Phase Phase 4
First received December 2, 2010
Last updated December 2, 2010
Start date March 2010
Est. completion date October 2010

Study information

Verified date March 2010
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Isfahan University of Medical Sciences
Study type Interventional

Clinical Trial Summary

Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on weight control and blood pressure management. Most studies in this regard have been conducted on postmenopausal or premenopausal women and there are few studies on female youths. Therefore, we are going to determine the effects of soy consumption on the weight, waist circumference and blood pressure in overweight and obese female youths. This was a cross-over randomized clinical trial which was conducted in 2010 in Isfahan on overweight or obese young female youths. After three weeks run-in, females were randomly assigned to consume a diet containing caw's milk or a diet in which only one glass of soy milk was substituted; each one for six weeks. Random sequencing generated in SPSS was used for allocating females in different group randomly. Patients were not blinded because they had to use soy milk in one period of trial and use caw's milk in another period.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date October 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria:Being in the age range of 18 to 30 and having body mass index more than 30 kg/m2 were the inclusion criteria.

Exclusion Criteria:Having allergy to soy product or caw's milk and not consuming the soy milk or caw's milk, incidence of chronic or acute diseases which make patients not to follow the research protocol or beginning to consume the medications were the exclusion criteria.

Study Design

N/A


Intervention

Dietary Supplement:
soy milk, Caw's milk


Locations

Country Name City State
Iran, Islamic Republic of Isfahan University of Medical Sciences Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

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