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OpenTrials
Completed

NCT Number: NCT00877825

The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dairy food control diet and high- and low- isoflavone soyfood diets

Procedure

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Study completion
2000
First posted
Apr 8, 2009
Registry last updated
Apr 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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