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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecan nut then no nut | Experimental | Participant will add pecan nuts to their diet during the first intervention arm, then they will cross over to the no nut diet arm |
|
| No nut then pecan nut | Experimental | Participant will consume a diet without nuts during the first intervention arm, then they will cross over to the arm where they will add pecan nuts to their diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pecan nut | Other | Dose - 2 ounces of pecan nuts, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vascular response at 3 months | Vascular response as measured by Pulse Wave Velocity (PWV) | Change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood lipids over 3 months | Blood lipids as measured by clinical lipid panel, including total, LDL and HDL cholesterol, and Tiglycerides | Change from baseline at 3 months |
| Change in markers of inflammation at 3 months |
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Inclusion Criteria:
BMI of 20-35 kg/m2, ability to understand the intervention instructions, Willingness to follow the dietary intervention, Willingness to provide biological samples (blood and stool) -
Exclusion Criteria:
Allergy to pecan or other nuts, Cognitive impairment due to dementia of any type and inability to understand or comply with intervention instructions, Use of menopausal hormone replacement therapy, Use of antibiotics or probiotics in the 2 months prior to enrollment, Uncontrolled diabetes with HbA1C of >9.5, Vegetarian/vegan, Any serious medical condition (such as chronic kidney disease of stage 3 or greater, heart failure, active cancer treatment, inflammatory bowel disease, etc.), Consumption of supplements that may interfere with vascular response or gut microbiome, Use of statin drugs for cholesterol lowering.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francene Steinberg, PhD | Contact | 530-752-0160 | fmsteinberg@ucdavis.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ragle Human Nutrition Center, UC Davis campus | Recruiting | Davis | California | 95616 | United States |
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Markers of inflammation as measured by Luminex cytokine panel IL-17
| 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 | 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 | 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 | Change from baseline at 3 months |
| Change in cognitive function - reaction time at 3 months | Reaction time task as measured by CANTAB assessments | Change from baseline at 3 months |
| Change in cognitive function - working memory at 3 months | Spatial working memory as assessed by CANTAB | Change from baseline at 3 months |
| Change in cognitive function - episodic memory at 3 months | Paired associates learning as measured by CANTAB | Change from baseline to 3 months |
| Change in cognitive function - sustained attention at 3 months | Attention measured via Rapid visual information processing using CANTAB | 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) | 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) | Change from baseline at 3 months |
| Change in mood over 3 months | Assessment of mood using the Affect Grid | Change from baseline to 3 months |
| Change in perceived stress over 3 months | Assessment of stress using the Perceived Stress Scale (PSS-10) | Change from baseline at 3 months |
| Change in anxiety at 3 months | Anxiety measured using the Generalized Anxiety disorder Scale (GAD-7) | 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) | Change from baseline at 3 months |
| Change in blood acute phase inflammatory response maker at 3 months | Acute phase inflammatory response measured by hsCRP | Change from baseline at 3 months |