Barley Protein and CVD

NCT00334308 | Completed Phase 2

• 1 other identifier: REB 02-113C
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Cardiovascular Disease; Diet Therapy

Outcome Measures

Primary Outcomes (1)

• total and LDL cholesterol, LDL:HDL cholesterol ratio

Secondary Outcomes (1)

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

Interventions

Barley protein bread or control (casein) bread PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

• 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.

  PMID: 20668250 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Interventions

Caseins; Bread

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David JA Jenkins, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Last Updated: January 21, 2009

Record last verified: 2009-01

Locations

CA (1)