Effect of Soymilk Replacement on Anthropometric and Blood Pressure Value

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01253876
First received: December 2, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Weight
Waist
Systolic Blood Pressure
Diastolic Blood Pressure
Dietary Supplement: soy milk, Caw's milk
Phase 4

Study Type: Interventional

Further study details as provided by Isfahan University of Medical Sciences:

Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soy milk Dietary Supplement: soy milk, Caw's milk
Experimental: Caw's milk Dietary Supplement: soy milk, Caw's milk

  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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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.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01253876

Locations
Iran, Islamic Republic of
Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01253876     History of Changes
Other Study ID Numbers: Soy milk weight blood pressure
Study First Received: December 2, 2010
Last Updated: December 2, 2010
Health Authority: Iran: Isfahan University of Medical Sciences

ClinicalTrials.gov processed this record on July 23, 2014