Influence of Walnut Intake on Vascular Function and Metabolism

NCT03900403 | Completed

• 1 other identifier: 1313232
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity; Endothelial Dysfunction; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (2)

• Reactive Hyperemia Index (RHI)

  Digital microvascular function as measured by the EndoPAT2000

  18 weeks

• Framingham Reactive Hyperemia Index (fRHI)

  Digital microvascular function as measured by the EndoPAT2000

  18 weeks

Secondary Outcomes (10)

• Collagen-Induced Platelet Aggregation

  18 weeks

• ADP-Induced Platelet Aggregation

  18 weeks

• Plasma Fatty Acids

  18 weeks

• Plasma Oxylipins

  18 weeks

• Esterified Oxylipins

  18 weeks

Other Outcomes (5)

• Blood Pressure

  18 weeks

• Complete Metabolic Panel

  18 weeks

• Complete Blood Cell Count

  18 weeks

Study Arms (2)

Habitual Intake

NO INTERVENTION

This will be the comparative arm, of 6 weeks before and after the study participant is on their habitual diet

Walnut Intake

EXPERIMENTAL

Experimental Arm of 12 weeks of Walnut Intake, with study visits at baseline (prior to walnut intake) and after 6 and 12 weeks of 40g of Walnut Intake.

Other: Walnut Intake

Interventions

Walnut Intake OTHER

40g of daily walnut intake for 12 weeks

Walnut Intake

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Department of Nutrition

Davis, California, 95616, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberta R Holt, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-arm study, comparing the effects of 12 weeks of 40g of walnut intake to 6 weeks of the study participant's habitual diet.

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 3, 2019
• Study Start: September 1, 2019
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)