Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cardiovascular Risk Factor
  • Endothelial Dysfunction
  • Overweight and Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention 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

Participation Requirements

Age
Between 45 years and 65 years
Gender
Only males

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 incorpo...

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.

Tracking Information

NCT #
NCT03900403
Collaborators
Not Provided
Investigators
Principal Investigator: Roberta R Holt, PhD University of California, Davis