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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Guelph Food Research Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University of Guelph
Glycemic Index Laboratories, Inc
Canadian Centre for Agri-food Research in Health and Medicine
Information provided by (Responsible Party):
Dan Ramdath, Guelph Food Research Centre
ClinicalTrials.gov Identifier:
NCT01547585
First received: March 5, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Cardiovascular Disease
CRP
Other: Standardized soy containing muffin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study

Resource links provided by NLM:


Further study details as provided by Guelph Food Research Centre:

Primary Outcome Measures:
  • Low Density Lipoprotein Cholesterol (LDL-Cholesterol) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • high sensitivity c-reactive protein (hsCRP) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 243
Study Start Date: March 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
- Isocaloric control muffins
Other: Standardized soy containing muffin
Standardized muffin containing two levels of soy
Other Name: Soy containing muffins
Experimental: Low Dose Soy
- Isocaloric muffins containing low dose of soy
Other: Standardized soy containing muffin
Standardized muffin containing two levels of soy
Other Name: Soy containing muffins
Experimental: High Dose Soy
- Isocaloric muffins containing high dose soy
Other: Standardized soy containing muffin
Standardized muffin containing two levels of soy
Other Name: Soy containing muffins

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females (not pregnant or lactating) aged 35-70 year
  • Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
  • Fasting plasma total cholesterol ≥5.0 and ≤8.0 mmol/L
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547585

Contacts
Contact: Dan Ramdath, PhD 519-780-8034 dan.ramdath@agr.gc.ca

Locations
Canada, Manitoba
Canadian Centre for Agri-food Research in Health and Medicine Not yet recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Heather Blewett, PhD    204-237-2954    hblewett@sbrc.ca   
Principal Investigator: Heather Blewett, PhD         
Canada, Ontario
Human Nutraceutical Research Unit. University of Guelph Not yet recruiting
Guelph, Ontario, Canada, N1G 2W1
Contact: Emily Padhi, BSc, MSc    519-824-4120 ext 53749    epadhi@gmail.com   
Contact: Alison Duncan, PhD, RD    519-824-4120 ext 53416    amduncan@uoguelph.ca   
Principal Investigator: Alison Duncan, PhD, RD         
Glycemic Index Laboratories, Inc Not yet recruiting
Toronto, Ontario, Canada, M5C 2N8
Contact: Janice Campbell, MSc, CCRP    416-861-0506 ext 201    jcampbell@gilabs.com   
Contact: Thomas Wolever, MD, PhD    416-978-5557    thomas.wolever@utoronto.ca   
Principal Investigator: Thomas Wolever, MD, PhD         
Sponsors and Collaborators
Guelph Food Research Centre
University of Guelph
Glycemic Index Laboratories, Inc
Canadian Centre for Agri-food Research in Health and Medicine
Investigators
Principal Investigator: Alison Duncan, PhD, RD University of Guelph
Principal Investigator: Thomas Wolever, MD, PhD Glycemic Index Laboratories, Inc
Principal Investigator: Heather Blewett, PhD Canadian Centre for Agri-food Research in Health and Medicine
  More Information

Publications:

Responsible Party: Dan Ramdath, Principal Investigator, Guelph Food Research Centre
ClinicalTrials.gov Identifier: NCT01547585     History of Changes
Other Study ID Numbers: SOY-CVD-2012, RBPI#1746
Study First Received: March 5, 2012
Last Updated: March 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by Guelph Food Research Centre:
Cholesterol
Cardiovascular disease
Soy
Dose-response

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 01, 2014