An interventional study of Walnut Intake in Overweight and Obesity, Endothelial Dysfunction and Cardiovascular Risk Factor, sponsored by University of California, Davis. Completed at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 20 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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Exclusion Criteria:
This will be the comparative arm, of 6 weeks before and after the study participant is on their habitual diet
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)
Digital microvascular function as measured by the EndoPAT2000
Time frame: 18 weeks
Framingham Reactive Hyperemia Index (fRHI)
Digital microvascular function as measured by the EndoPAT2000
Time frame: 18 weeks
Collagen-Induced Platelet Aggregation
Optical platelet aggregometry
Time frame: 18 weeks
ADP-Induced Platelet Aggregation
Optical platelet aggregometry
Time frame: 18 weeks
Plasma Fatty Acids
Circulating levels of non-esterified fatty acids
Time frame: 18 weeks
Plasma Oxylipins
Circulating levels of non-esterified oxylipins
Time frame: 18 weeks
Esterified Oxylipins
Lipoprotein esterified oxylipins
Time frame: 18 weeks
Esterified Fatty Acids
Lipoprotein esterified fatty acids
Time frame: 18 weeks
Urolithin Metabolites
Conjugated and unconjugated urolithins
Time frame: 18 weeks
Ellagitannin Metabolites
Conjugated and unconjugated Ellagitanin-derived metabolites
Time frame: 18 weeks
Total Nitrate and Nitrite
Total nitrate derived from the diet
Time frame: 18 weeks
Nitric Oxide metabolites (RNOX)
Nitric oxide metabolites produced from the intervention
Time frame: 18 weeks
Blood Pressure
Office blood pressure
Time frame: 18 weeks
Complete Metabolic Panel
Will include liver enzymes and glucose
Time frame: 18 weeks
Complete Blood Cell Count
w Will include total platelet number and mean platelet volume
Time frame: 18 weeks
Lipid Panel
Will assess fasting cholesterol and triglyceride levels
Time frame: 18 weeks
Skin Health
Will assess fine facial wrinkles and redness
Time frame: 18 weeks
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of California, Davis