Effects of California Walnuts on Vascular Function in Postmenopausal Women
|ClinicalTrials.gov Identifier: NCT01072864|
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : November 1, 2010
To determine the potential acute cardiovascular benefits of California Walnuts in postmenopausal women of ages 55-70.
Primary outcome measures:
- Vascular function
- Platelet reactivity
We hypothesize that the consumption of California walnuts will improve vascular function and platelet reactivity.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Other: Walnuts||Phase 1|
Epidemiological studies have shown that consumption of high amounts of plant foods, such as nuts, fruits and vegetables, appears to be protective against chronic diseases including heart disease, stroke, diabetes mellitus and metabolic syndrome. In recent years, numerous studies indicate that consumption of walnuts mainly containing α-linolenic acid (ALA), L-arginine and polyphenols beneficially alters vascular function and reduces inflammatory biomarkers. Recent studies have reported that consumption of walnuts is associated with beneficial effects in prevention of chronic diseases by favorably altering human serum profiles (i.e. decrease in LDL cholesterol and triglycerides and increase in HDL cholesterol and apolipoprotein A1) which are closely involved in the development of cardiovascular disease (CVD). In addition, recent reports by Dr. Ros and his colleagues indicate that addition of walnuts to a high-fat meal can improve endothelial function. This favorable influence on vasoactivity has been attributed to the antioxidant and anti-inflammatory properties of components of walnuts.
Due to their age and menopausal status, postmenopausal women in particular, are at a greater risk population for developing CVD. Males tend to show greater rates of CVD than pre-menopausal women, while women following menopause show an increase in the rates of CVD. This increase is associated with endothelial dysfunction and decreased vasodilation which are apparently expressed after menopause and become worse with age. In this study, we will define the effects of consuming California walnuts on vascular health.
We hypothesize that consumption of California walnuts, which are particularly rich in ALA, L-arginine and polyphenols, will improve endothelial function and platelet reactivity in an at-risk population of postmenopausal women 50-70 years of age.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of California Walnuts on Vascular Function in Postmenopausal Women|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
|Experimental: 5 g of walnuts||
Consumption of 5 g of walnuts.
|Experimental: 20 g of walnuts||
Consumption of 20 g of walnuts.
|Experimental: 30 g of walnuts||
Consumption of 30 g of walnuts.
|Experimental: 40 g of walnuts||
Consumption of 40 g of walnuts.
- Peripheral Arterial Tonometry (PAT) [ Time Frame: 2 and 4 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072864
|United States, California|
|Ragle Human Nutrition Research Center|
|Davis, California, United States, 95616|
|Principal Investigator:||Robert M. Hackman, PhD||University of California, Davis|