Cardiovascular Disease Clinical Trial
Official title:
Barley Protein and Coronary Heart Disease Risk Reduction
NCT number | NCT00334308 |
Other study ID # | REB 02-113C |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | June 6, 2006 |
Last updated | January 16, 2009 |
Verified date | January 2009 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The Question posed is: Does an barley protein concentrate have health benefits similar to those demonstrated for soy protein foods which would justify the use of the non-fiber components of barley as functional food ingredients? Hypotheses: 1. Cholesterol Lowering: There is good evidence indicating that soy protein lowers serum cholesterol levels. The evidence was strong enough for a health claim for coronary heart disease risk reduction to be approved by the FDA. In addition, we have found that wheat gluten significantly reduced serum triglyceride levels. However, there is a need to assess the possible health benefits other vegetable protein sources. Barley is grown in relatively large amounts in Canada and barley protein would be a readily available vegetable protein source if health attributes could be ascribed to it. In addition other components of barley, including plant sterols and phenolics, may have hypocholesterolemic and antioxidant properties. 2. Antioxidant: In addition to cholesterol-lowering and possibly of equal importance in terms of prevention of cardiovascular and other chronic diseases, the barley phenolics associated with barley protein and may have added benefits as antioxidants. 3. Markers of Inflammation: Barley components are considered to be hypoallergenic. Hence their use in the cosmetic industry. Auto-immune and inflammatory responses are associated with increased CHD risk. Barley protein consumption may therefore reduce the levels of the pro-inflammatory cytokines; and the acute phase proteins. 4. Arterial Dilatation: Barley proteins may also have beneficial effects on vascular reactivity which may reduce CHD risk on account of their higher arginine:lysine ratio. Arginine enhances nitric oxide synthesis associated with endothelial relaxation and arterial dilatation. Barley may therefore increase pulmonary nitric oxide levels.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - men and postmenopausal women with mild- to-moderate hypercholesterolemia - Body mass index >18 kg/m2 and < 36 kg/m2. - treated by diet - Alcohol intake < 14 drinks per week. - Fasting plasma triglyceride (TG) concentration > 0.5 mmol/l and < 4.5 mmol/l. - Fasting plasma LDL cholesterol concentration > 3.5 mmol/l at diagnosis. Exclusion Criteria: - Child-bearing women - Taking cholesterol lowering medications at the start of the study, unless their LDL-cholesterol levels are >3.5 mmol/L.However, with their physician's approval those who wish to join but are already taking cholesterol lowering medications with low LDL-cholesterol levels (e.g. <2.5 mmol/L) may join the study providing the medications are stopped for one month. - Change the type or dose of their drug treatment during the study - Patients judged as having a likelihood of being non-compliant with instructions for whatever reason - Food allergies - Evidence or history of diabetes, renal liver disease or gastrointestinal disease - Recent (within 6 months)) major cardiovascular event (stroke or myocardial infarction) - Secondary causes of hypercholesterolemia (or untreated hypothyroidism) - Uncontrolled blood pressure - Major disability or disorder such as liver disease, renal failure or cancer or with major surgery < 6 months prior to randomization |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total and LDL cholesterol, LDL:HDL cholesterol ratio | |||
Secondary | Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size; oxidative stress,inflammatory biomarkers |
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