Effects of California Walnuts on Vascular Function in Postmenopausal Women

Cardiovascular Diseases Clinical Trial

Official title:

Effects of California Walnuts on Vascular Function in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072864
• Other study ID #: 200917508-1
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2010
• Last updated: October 28, 2010
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• 50 to 70 years of age

• Lack of menses in the last year and FSH 23-116.3 mlU/mL

• Subject is willing and able to comply with the study protocols.

• Subject is willing to consume up to 40 g of California walnuts.

• BMI 18.5-34.9 kg/m2

• Weight = 110 pounds

Exclusion Criteria:

• BMI = 35 kg/m2

• Weight <110 pounds

• Diabetes

• Taking anticoagulation medication including NSAIDs

• Blood pressure = 160/90 mm Hg

• PFA-100 readings 10 % outside of normal reference range (normal reference range for ADP-Collagen: 71-118 sec; Epinephrine-Collagen: 94-193 sec).

• Renal or liver disease

• Heart disease, which includes cardiovascular events and Stroke

• Cushing's syndrome

• Chronic/routine high intensity exercise

• Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT

• Abnormal Liver, CBC or CMP (laboratory values outside the reference range) if determined to be clinically significant.

• History of cancer

• History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.

• Use of MAOI inhibitor within the last 1 year (e.g. phenelzine (Nardil), tranylcypromine (Parnate), etc)

• Malabsorption

• Anxiety medications

• Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, ACE-inhibitors, and beta-blockers.

• Asthma (can be worsened by mild to moderate food allergies).

• Indications of substance or alcohol abuse within the last 3 years

• Use of multivitamin/mineral supplements

• Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months.

• Nut allergies

• Soy-derived supplements

• Soy/soy products consumption > 2 servings/week

• Hormone replacement therapy

• Alcohol consumption > 1 drink/day (i.e. 1 bottle of beer, ½ glass of wine, and 1 shot of hard liquor)

• Fruit consumption = 3 cups (6 servings)/day

• Vegetable consumption = 4 cups (8 servings)/day

• Grain consumption = 8 oz/day

• Meat and Beans = 7 oz/day

• Fatty Fish = 3 times/week

• Milk = 5 cups/day

• Oil = 8 tsp/day

• Coffee/tea = 3 cups/day

• Dark chocolate = 3 oz/day

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Walnuts
Consumption of 5 g of walnuts.
• Walnuts
Consumption of 20 g of walnuts.
• Walnuts
Consumption of 30 g of walnuts.
• Walnuts
Consumption of 40 g of walnuts.

Locations

Country	Name	City	State
United States	Ragle Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	California Walnut Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral Arterial Tonometry (PAT)		2 and 4 hours	No