The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Cardiovascular Diseases Clinical Trial

Official title:

The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877825
• Other study ID #: REB235U
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2009
• Last updated: April 7, 2009
• Est. completion date: April 2000

Study information

• Verified date: April 2009
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• men and post-menopausal women

• LDL-C > 4.1mmol/L at recruitment

• living within a 40 km radius of St. Michael's Hospital

Exclusion Criteria:

• lipid lowering medications

• clinical or biochemical evidence of diabetes, renal or hepatic disease

• body mass index (BMI) >38 kg/m2

• antibiotic use within the last three months

• hormone replacement therapy

• smoking or significant alcohol use (>1 drink/d)

• triglyceride level > 4.0mmol/L

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemia
• Hyperlipidemias

Intervention

Procedure:
• dairy food control diet and high- and low- isoflavone soyfood diets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto