Influence of Walnut Intake on Vascular Function and Metabolism
Keywords
Abstract
Description
A dietary intervention trial will be conducted to achieve the following objectives and outcomes:
Objective 1: Determine the 12 week change in bioactive lipid mediators, and their relationship to vascular function and platelet reactivity in overweight or obese postmenopausal women with walnut incorporation into their habitual diet.
Objective 2: Assess the contribution of metabolic phenotype on the variance in biomarker response that includes both primary metabolism and urolithin metabotype.
Expected Outcomes: Forty g of daily walnut intake for six- and 12- weeks is predicted to positively impact the production of bioactive lipid mediators known to favorably regulate cardiovascular and inflammatory signaling. AA derived oxylipins produced from COX, LOX, and CYP epoxygenases are known as regulators of inflammation, platelet activation and vascular function. Therefore, understanding how certain foods such as walnuts can change the relative ratio of PUFA substrates (i.e., AA, ALA, LA, EPA and DHA), and their subsequent bioactive species produced through these enzyme pathways is necessary for the refinement of dietary recommendations with regard to specific foods and dietary patterns aimed at reducing the risk of chronic disease. Although a positive outcome is predicted, there may be substantial variability in response. To explore potential genetic and dietary factors that may contribute to the variability in response to the above functional markers, primary metabolism and urolithin metabotype will be assessed.
Objective 3: Assess the influence of 12 weeks of walnut intake on facial wrinkles in postmenopausal women.
Expected Outcome: Tweleve weeks of 40 g of walnut intake will improve facial wrinkles and erythema in the study population, and the improvements will be related to changes in metabotype.
Dates
| Last Verified: | 09/30/2019 |
| First Submitted: | 03/30/2019 |
| Estimated Enrollment Submitted: | 03/30/2019 |
| First Posted: | 04/02/2019 |
| Last Update Submitted: | 10/17/2019 |
| Last Update Posted: | 10/20/2019 |
| Actual Study Start Date: | 08/31/2019 |
| Estimated Primary Completion Date: | 12/29/2020 |
| Estimated Study Completion Date: | 02/27/2021 |
Condition or disease
Intervention/treatment
Other: Walnut Intake
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Habitual Intake This will be the comparative arm, of 6 weeks before and after the study participant is on their habitual diet | |
| Experimental: Walnut Intake 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 40g of daily walnut intake for 12 weeks |
Eligibility Criteria
| Ages Eligible for Study | 45 Years To 45 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Cannabis use - Screening LDL ≥ 190 mg/dl for those who have 0-1 major risk factors apart from LDL cholesterol (i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp) - Screening LDL ≥ 160 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL]. (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp); - Screening LDL ≥ 130 mg/dl for those who have 2 major risk factors apart from LDL cholesterol [i.e. family history of premature coronary artery disease (male first degree relative < 55 years; CHD in female first degree relative < 65 years), cigarette smoker, HDL-C ≤ 40 mg/dL], and a Framingham 10-year Risk Score 10-20% (using NCEP calculator http://cvdrisk.nhlbi.nih.gov/calculator.asp). - Current enrollee in a clinical research study. |
Outcome
Primary Outcome Measures
1. Reactive Hyperemia Index (RHI) [18 weeks]
2. Framingham Reactive Hyperemia Index (fRHI) [18 weeks]
Secondary Outcome Measures
1. Collagen-Induced Platelet Aggregation [18 weeks]
2. ADP-Induced Platelet Aggregation [18 weeks]
3. Plasma Fatty Acids [18 weeks]
4. Plasma Oxylipins [18 weeks]
5. Esterified Oxylipins [18 weeks]
6. Esterified Fatty Acids [18 weeks]
7. Urolithin Metabolites [18 weeks]
8. Ellagitannin Metabolites [18 weeks]
9. Total Nitrate and Nitrite [18 weeks]
10. Nitric Oxide metabolites (RNOX) [18 weeks]
Other Outcome Measures
1. Blood Pressure [18 weeks]
2. Complete Metabolic Panel [18 weeks]
3. Complete Blood Cell Count [18 weeks]
4. Lipid Panel [18 weeks]
5. Skin Health [18 weeks]
