Effect of Soymilk Replacement on Anthropometric and Blood Pressure Value

Phase 4

Completed

• Conditions: Weight; Waist; Systolic Blood Pressure; Diastolic Blood Pressure
• Interventions: Dietary Supplement: soy milk, Caw's milk

• Registration Number: NCT01253876
• Lead Sponsor: Isfahan University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Last Update Submitted: 2010-12-02
• Study First Posted: 2010-12-03
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Soy milk	soy milk, Caw's milk	-
Caw's milk	soy milk, Caw's milk	-

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of