Influence of Walnut Intake on Vascular Function and Metabolism

Completed · Not applicable

Conditions studied: Overweight and Obesity, Endothelial Dysfunction, Cardiovascular Risk Factor

In brief

This study seeks to confirm and extend previous finding that four weeks of daily intake of 40 g of walnuts improve microvascular function, increasing the reactive hyperemia index (RHI), effects which were greatest in individuals with the worst initial RHI and correlating to circulating levels of vasoactive plasma epoxides. The current trial will enroll postmenopausal women who are at risk for cardiovascular disease due to their menopausal status and increased central adiposity. The initial trial focused on non-esterified (i.e. plasma) derived oxylipins, but substantial and unique changes were also observed in the esterified lipoprotein pool. The current study will add the esterified lipoprotein pool, important, as the mechanisms by which walnut intake influences endothelial function are currently undefined, but may include lipoprotein induced modulation of vascular hemostasis. As a secondary objective, primary metabolism and urolithin metabotype will be analyzed as a way to capture the influence of potential differences in habitual diet and metabolism on physiologic response. Therefore, this study will combine measures of cardiovascular physiology, metabolomics, and walnut-derived metabolite analyses to assess the 12 week influence of 40 g of daily walnut intake on the health of overweight and obese postmenopausal women.

Key facts

Study ID

NCT03900403

Run by

University of California, Davis

People needed

20

Starts

2019-09-01

Expected to finish

2023-06-14

Last updated by the study team

2023-08-31

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Postmenopausal female: 45-65 years
• Women: lack of menses for at least two years.
• Subject is willing and able to comply with the study protocols.
• Subject is willing to participate in all study procedures
• BMI 25.0 - 35 kg/m2

You may not qualify if…

• BMI ≥ 35 kg/m2
• Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.4
• Dislike or allergy for walnuts or walnut products
• Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
• Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
• Fruit consumption ≥ 3 cups/day
• Regular consumption of nuts (2-3 servings/week)
• Vegetable consumption ≥ 4 cups/day for females
• Coffee/tea ≥ 3 cups/day
• Dark chocolate ≥ 3 oz/day
• Self-reported restriction of physical activity due to a chronic health condition
• Self-reported chronic/routine high intensity exercise
• Self-reported diabetes
• Blood pressure ≥ 140/90 mm Hg
• Self-reported renal or liver disease
• Self-reported heart disease, which includes cardiovascular events and stroke
• Peripheral artery disease, Raynaud's syndrome or disease
• Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
• Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
• Self-reported cancer within past 5 years
• Self-reported malabsorption
• Currently taking prescription drugs or supplements.
• Supplement use other than a general formula of vitamins and minerals that meet the RDA
• Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
• Indications of substance or alcohol abuse within the last 3 years

Where it is running

• Department of Nutrition — Davis, California, United States

Full record on ClinicalTrials.gov

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