Ragle Human Nutrition Center, UC Davis campus
Davis, California, 95616, United States
Location status: Recruiting
NCT Number: NCT07227259
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.
Interested in participating?
Request Info45 year–75 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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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Dose - 2 ounces of pecan nuts, daily
Time frame: Change from baseline at 3 months
Vascular response as measured by Pulse Wave Velocity (PWV)
Time frame: Change from baseline at 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
Markers of inflammation as measured by Luminex cytokine panel IL-17
Time frame: Change from baseline at 3 months
Gut microbiome profile as measured by fecal 16S rRNA gene sequencing
Time frame: Change from baseline at 3 months
Blood marker of intestinal permeability as measured by ELISA for LBP and LPS
Time frame: Change from baseline 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
Reaction time task as measured by CANTAB assessments
Time frame: Change from baseline at 3 months
Spatial working memory as assessed by CANTAB
Time frame: Change from baseline to 3 months
Paired associates learning as measured by CANTAB
Time frame: Change from baseline at 3 months
Attention measured via Rapid visual information processing using CANTAB
Time frame: Change from baseline 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
Self-rated questionnaire of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline to 3 months
Assessment of mood using the Affect Grid
Time frame: Change from baseline at 3 months
Assessment of stress using the Perceived Stress Scale (PSS-10)
Time frame: Change from baseline at 3 months
Anxiety measured using the Generalized Anxiety disorder Scale (GAD-7)
Time frame: Change from baseline at 3 months
Assessment of depressive symptoms using the Beck Depression Inventory-II (BDI-II)
Time frame: Change from baseline at 3 months
Acute phase inflammatory response measured by hsCRP
Contact information is provided by the study sponsor or research team.
University of California, Davis
Other
Assessment of Systematic Health Properties of Pecan Nut Consumption: Gut, Vascular, Metabolic and Cognitive Outcomes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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