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Barley Protein and CVD

Primary Purpose

Hypercholesterolemia, Cardiovascular Disease, Diet Therapy

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Barley protein bread or control (casein) bread
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Outcomes

Primary Outcome Measures

total and LDL cholesterol, LDL:HDL cholesterol ratio

Secondary Outcome Measures

Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size; oxidative stress,inflammatory biomarkers

Full Information

First Posted
June 6, 2006
Last Updated
January 16, 2009
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00334308
Brief Title
Barley Protein and CVD
Official Title
Barley Protein and Coronary Heart Disease Risk Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
Design: The effect of oat protein extract will be assessed in one-month feeding studies of forty healthy men and women with raised serum cholesterol levels. Two breads will be prepared, one control and one providing 45 g/d barley protein to be fed for one month each in a randomized crossover design. Diets: The diets will be the subjects' usual diets which appropriately will be NCEP Step 2 diets for patients treated without medications with this degree of hyperlipidemia. Those who are not on an NCEP Step 2 diet will be instructed accordingly. During the first phase, the two one-week recorded diets for each patient will be photocopied and returned to the patient to be used as the dietary model for the subsequent period. We have found that this approach is effective in stabilizing the diets in our soy protein studies. Supplements: Will be breads with test and control supplements providing the identical daily energy intake. The increase in protein in the barley supplements will be matched by the use of protein from milk protein (casein). Similarly the increased polyunsaturated, monounsaturated and saturated fatty acids in the test supplement will be matched by addition of an appropriate blend of oils in the control. Baked goods will be prepared at our clinic and a seven-day supply will be provided to each participant at the beginning of each week. The exact formulation of the supplements will involve product development, palatability testing and chemical analysis of the prototypes in the initial phase of the study. Compliance: compliance will be assessed from completed weekly diet records where supplement intake is recorded daily. These records will be reviewed by a dietitian with the subject at the end of the week. In addition, uneaten supplements will be returned, weighed and noted on the menu plans by the dietitian. Diet records will also be assessed to ensure the predetermined diet plan is followed according to the phase one recorded diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Cardiovascular Disease, Diet Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Barley protein bread or control (casein) bread
Primary Outcome Measure Information:
Title
total and LDL cholesterol, LDL:HDL cholesterol ratio
Secondary Outcome Measure Information:
Title
Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size; oxidative stress,inflammatory biomarkers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David JA Jenkins, MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20668250
Citation
Jenkins DJ, Srichaikul K, Wong JM, Kendall CW, Bashyam B, Vidgen E, Lamarche B, Rao AV, Jones PJ, Josse RG, Jackson CJ, Ng V, Leong T, Leiter LA. Supplemental barley protein and casein similarly affect serum lipids in hypercholesterolemic women and men. J Nutr. 2010 Sep;140(9):1633-7. doi: 10.3945/jn.110.123224. Epub 2010 Jul 28.
Results Reference
derived

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Barley Protein and CVD

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