Clinical trial NCT01547585: A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy
Official title: A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Cardiovascular Disease
CRP
Keywords: Cholesterol
Cardiovascular disease
Soy
Dose-response
Lead sponsor: Guelph Food Research Centre
Sponsor class: OTHER_GOV
Collaborators: name: University of Guelph
name: Glycemic Index Laboratories, Inc
name: Canadian Centre for Agri-Food Research in Health and Medicine
First posted: 2012-03-08
Enrollment: 243
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Low Density Lipoprotein Cholesterol (LDL-Cholesterol)
timeFrame: 6 weeks
Secondary outcomes:
measure: high sensitivity c-reactive protein (hsCRP)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Canadian Centre for Agri-food Research in Health and Medicine
state: Manitoba
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit. University of Guelph
state: Ontario
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc
state: Ontario
Study officials:
affiliation: University of Guelph
name: Alison Duncan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Centre for Agri-Food Research in Health and Medicine
name: Heather Blewett, PhD
role: PRINCIPAL_INVESTIGATOR
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