Influence of Walnut Intake on Vascular Function and Metabolism
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|ClinicalTrials.gov Identifier: NCT03900403|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity Endothelial Dysfunction Cardiovascular Risk Factor||Other: Walnut Intake||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-arm study, comparing the effects of 12 weeks of 40g of walnut intake to 6 weeks of the study participant's habitual diet.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Influence of Daily Walnut Intake on Vascular Function and Associated Changes in Lipid Mediators and Primary Metabolites.|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||February 28, 2021|
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
- Reactive Hyperemia Index (RHI) [ Time Frame: 18 weeks ]Digital microvascular function as measured by the EndoPAT2000
- Framingham Reactive Hyperemia Index (fRHI) [ Time Frame: 18 weeks ]Digital microvascular function as measured by the EndoPAT2000
- Collagen-Induced Platelet Aggregation [ Time Frame: 18 weeks ]Optical platelet aggregometry
- ADP-Induced Platelet Aggregation [ Time Frame: 18 weeks ]Optical platelet aggregometry
- Plasma Fatty Acids [ Time Frame: 18 weeks ]Circulating levels of non-esterified fatty acids
- Plasma Oxylipins [ Time Frame: 18 weeks ]Circulating levels of non-esterified oxylipins
- Esterified Oxylipins [ Time Frame: 18 weeks ]Lipoprotein esterified oxylipins
- Esterified Fatty Acids [ Time Frame: 18 weeks ]Lipoprotein esterified fatty acids
- Urolithin Metabolites [ Time Frame: 18 weeks ]Conjugated and unconjugated urolithins
- Ellagitannin Metabolites [ Time Frame: 18 weeks ]Conjugated and unconjugated Ellagitanin-derived metabolites
- Total Nitrate and Nitrite [ Time Frame: 18 weeks ]Total nitrate derived from the diet
- Nitric Oxide metabolites (RNOX) [ Time Frame: 18 weeks ]Nitric oxide metabolites produced from the intervention
- Blood Pressure [ Time Frame: 18 weeks ]Office blood pressure
- Complete Metabolic Panel [ Time Frame: 18 weeks ]Will include liver enzymes and glucose
- Complete Blood Cell Count [ Time Frame: 18 weeks ]w Will include total platelet number and mean platelet volume
- Lipid Panel [ Time Frame: 18 weeks ]Will assess fasting cholesterol and triglyceride levels
- Skin Health [ Time Frame: 18 weeks ]Will assess fine facial wrinkles and redness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900403
|Contact: Roberta R Holt, PhDemail@example.com|
|Contact: Carl L Keen, PhDfirstname.lastname@example.org|
|United States, California|
|Department of Nutrition||Recruiting|
|Davis, California, United States, 95616|
|Contact: Roberta R Holt, PhD 530-752-4950 email@example.com|
|Principal Investigator:||Roberta R Holt, PhD||University of California, Davis|