NCT01253876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
Last Updated

December 3, 2010

Status Verified

March 1, 2010

Enrollment Period

5 months

First QC Date

December 2, 2010

Last Update Submit

December 2, 2010

Conditions

Study Arms (2)

Soy milk

EXPERIMENTAL
Dietary Supplement: soy milk, Caw's milk

Caw's milk

EXPERIMENTAL
Dietary Supplement: soy milk, Caw's milk

Interventions

soy milk, Caw's milkDIETARY_SUPPLEMENT
Caw's milkSoy milk

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

MeSH Terms

Conditions

Body Weight

Interventions

Soy Milk

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFoodFood and Beverages

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

December 3, 2010

Record last verified: 2010-03

Locations