- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01253876
Effect of Soymilk Replacement on Anthropometric and Blood Pressure Value
December 2, 2010 updated by: Isfahan University of Medical Sciences
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Isfahan, Iran, Islamic Republic of
- Isfahan University of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Soy milk
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EXPERIMENTAL: Caw's milk
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (ACTUAL)
August 1, 2010
Study Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
December 2, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (ESTIMATE)
December 3, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 3, 2010
Last Update Submitted That Met QC Criteria
December 2, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soy milk weight blood pressure
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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