A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy (SOY-LDL)

March 10, 2015 updated by: Dan Ramdath, Guelph Food Research Centre

A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study

This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial. All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy. Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.

Study Overview

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Not Applicable

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

    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Canadian Centre for Agri-food Research in Health and Medicine
    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • Human Nutraceutical Research Unit. University of Guelph
      • Toronto, Ontario, Canada, M5C 2N8
        • Glycemic Index Laboratories, Inc

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

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females (not pregnant or lactating) aged 30-70 year
  • Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
  • Fasting plasma total cholesterol ≥5.0
  • Fasting plasma LDL cholesterol ≥3.0 and <5.0 mmol/L.

Exclusion Criteria:

  • Fasting plasma triglycerides ≥4.0 mmol/L
  • Abnormal liver and kidney function
  • Unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
  • Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
  • Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
  • Major surgical or medical events within the past 3 months;
  • Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
  • Consumption of a diet containing ≥15% of energy from saturated fat;
  • Any food allergy or aversion or unwillingness to eat wheat, soy or milk;
  • Consumption of ≥5 servings per week of soy based food products;
  • Consumption of an average of >2 alcoholic beverages per day;
  • Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars

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?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
- Isocaloric control muffins
Standardized muffin containing two levels of soy
Other Names:
  • Soy containing muffins
EXPERIMENTAL: Low Dose Soy
- Isocaloric muffins containing low dose of soy
Standardized muffin containing two levels of soy
Other Names:
  • Soy containing muffins
EXPERIMENTAL: High Dose Soy
- Isocaloric muffins containing high dose soy
Standardized muffin containing two levels of soy
Other Names:
  • Soy containing muffins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Low Density Lipoprotein Cholesterol (LDL-Cholesterol)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
high sensitivity c-reactive protein (hsCRP)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alison Duncan, PhD, RD, University of Guelph
  • Principal Investigator: Heather Blewett, PhD, Canadian Centre for Agri-food Research in Health and Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SOY-CVD-2012
  • RBPI#1746 (OTHER_GRANT: Adriculture and Agri-Food Canada)

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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