Healthy Adults
Conditions
Keywords
pecan nut, cardiovascular, gut microbiome, cognitive
Brief summary
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.
Interventions
OTHERpecan nut
Dose - 2 ounces of pecan nuts, daily
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vascular response at 3 months | Change from baseline at 3 months | Vascular response as measured by Pulse Wave Velocity (PWV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood lipids over 3 months | Change from baseline at 3 months | Blood lipids as measured by clinical lipid panel, including total, LDL and HDL cholesterol, and Tiglycerides |
| Change in markers of inflammation at 3 months | change from baseline at 3 months | Markers of inflammation as measured by Luminex cytokine panel IL-17 |
| Change in gut microbiome profile at 3 months | Change from baseline at 3 months | Gut microbiome profile as measured by fecal 16S rRNA gene sequencing |
| Change in blood markers of intestinal permeability at 3 months. | Change from baseline at 3 months | Blood marker of intestinal permeability as measured by ELISA for LBP and LPS |
| Change in blood markers of intestinal permeability at 3 months | Change from baseline at 3 months | Blood biomarker of intestinal permeability and immune activation as measured by ELISA of sCD14 |
| Change in cognitive function - reaction time at 3 months | Change from baseline at 3 months | Reaction time task as measured by CANTAB assessments |
| Change in cognitive function - working memory at 3 months | Change from baseline at 3 months | Spatial working memory as assessed by CANTAB |
| Change in cognitive function - episodic memory at 3 months | Change from baseline to 3 months | Paired associates learning as measured by CANTAB |
| Change in cognitive function - sustained attention at 3 months | Change from baseline at 3 months | Attention measured via Rapid visual information processing using CANTAB |
| Change in quality of life at 3 months | Change from baseline at 3 months | Self-perceived quality of life questionnaire assessed using World Health Organization Qualigy of Life Instruments (WHOQOL-BREF) |
| Change in sleep quality at 3 months | Change from baseline at 3 months | Self-rated questionnaire of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) |
| Change in mood over 3 months | Change from baseline to 3 months | Assessment of mood using the Affect Grid |
| Change in perceived stress over 3 months | Change from baseline at 3 months | Assessment of stress using the Perceived Stress Scale (PSS-10) |
| Change in anxiety at 3 months | Change from baseline at 3 months | Anxiety measured using the Generalized Anxiety disorder Scale (GAD-7) |
| Change in depressive symptoms at 3 months | Change from baseline at 3 months | Assessment of depressive symptoms using the Beck Depression Inventory-II (BDI-II) |
| Change in blood acute phase inflammatory response maker at 3 months | Change from baseline at 3 months | Acute phase inflammatory response measured by hsCRP |
Countries
United States
Contacts
CONTACTFrancene Steinberg, PhD
Outcome results
None listed