The main goal of this clinical study is to see if consuming pecan nuts will result in improvements in overall body metabolism such as in blood lipids, markers of inflammation, blood pressure, cognitive performance and changes in bacteria living in the gut in adults 45 to 75 years of age. Participants will take part in two 3-month intervention periods, separated by 4-6 weeks, in random order ( a total of approximately 7 months). During one intervention period, they will include pecan nuts in their diet each day, while during the other intervention period they will avoid pecans in their diet. There will be an initial screening visit to evaluate eligibility and four study visits to the clinic. Participants will be asked to complete some questionnaires about their diet, physical and cognitive health, and provide blood and stool samples, and have their blood pressure measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
Dose - 2 ounces of pecan nuts, daily
Ragle Human Nutrition Center, UC Davis campus
Davis, California, United States
RECRUITINGChange in vascular response at 3 months
Vascular response as measured by Pulse Wave Velocity (PWV)
Time frame: Change from baseline at 3 months
Change in blood lipids over 3 months
Blood lipids as measured by clinical lipid panel, including total, LDL and HDL cholesterol, and Tiglycerides
Time frame: Change from baseline at 3 months
Change in markers of inflammation at 3 months
Markers of inflammation as measured by Luminex cytokine panel IL-17
Time frame: change from baseline at 3 months
Change in gut microbiome profile at 3 months
Gut microbiome profile as measured by fecal 16S rRNA gene sequencing
Time frame: Change from baseline at 3 months
Change in blood markers of intestinal permeability at 3 months.
Blood marker of intestinal permeability as measured by ELISA for LBP and LPS
Time frame: Change from baseline at 3 months
Change in blood markers of intestinal permeability at 3 months
Blood biomarker of intestinal permeability and immune activation as measured by ELISA of sCD14
Time frame: Change from baseline at 3 months
Change in cognitive function - reaction time at 3 months
Reaction time task as measured by CANTAB assessments
Time frame: Change from baseline at 3 months
Change in cognitive function - working memory at 3 months
Spatial working memory as assessed by CANTAB
Time frame: Change from baseline at 3 months
Change in cognitive function - episodic memory at 3 months
Paired associates learning as measured by CANTAB
Time frame: Change from baseline to 3 months
Change in cognitive function - sustained attention at 3 months
Attention measured via Rapid visual information processing using CANTAB
Time frame: Change from baseline at 3 months
Change in quality of life at 3 months
Self-perceived quality of life questionnaire assessed using World Health Organization Qualigy of Life Instruments (WHOQOL-BREF)
Time frame: Change from baseline at 3 months
Change in sleep quality at 3 months
Self-rated questionnaire of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline at 3 months
Change in mood over 3 months
Assessment of mood using the Affect Grid
Time frame: Change from baseline to 3 months
Change in perceived stress over 3 months
Assessment of stress using the Perceived Stress Scale (PSS-10)
Time frame: Change from baseline at 3 months
Change in anxiety at 3 months
Anxiety measured using the Generalized Anxiety disorder Scale (GAD-7)
Time frame: Change from baseline at 3 months
Change in depressive symptoms at 3 months
Assessment of depressive symptoms using the Beck Depression Inventory-II (BDI-II)
Time frame: Change from baseline at 3 months
Change in blood acute phase inflammatory response maker at 3 months
Acute phase inflammatory response measured by hsCRP
Time frame: Change from baseline at 3 months
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