- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07227259
Health Properties of Pecan Nut Consumption
Assessment of Systematic Health Properties of Pecan Nut Consumption: Gut, Vascular, Metabolic and Cognitive Outcomes
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 Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francene Steinberg, PhD
- Phone Number: 530-752-0160
- Email: fmsteinberg@ucdavis.edu
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Recruiting
- Ragle Human Nutrition Center, UC Davis campus
-
Contact:
- Francene Steinberg, PhD
- Phone Number: 530-752-0160
- Email: fmsteinberg@ucdavis.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pecan nut then no nut
Participant will add pecan nuts to their diet during the first intervention arm, then they will cross over to the no nut diet arm
|
Dose - 2 ounces of pecan nuts, daily
|
|
Experimental: No nut then pecan nut
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.
|
Dose - 2 ounces of pecan nuts, daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in vascular response at 3 months
Time Frame: Change from baseline at 3 months
|
Vascular response as measured by Pulse Wave Velocity (PWV)
|
Change from baseline at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood lipids over 3 months
Time Frame: Change from baseline at 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
Time Frame: change from baseline at 3 months
|
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
Time Frame: Change from baseline 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.
Time Frame: Change from baseline 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
Time Frame: Change from baseline 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
Time Frame: Change from baseline 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
Time Frame: Change from baseline 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
Time Frame: Change from baseline to 3 months
|
Paired associates learning as measured by CANTAB
|
Change from baseline to 3 months
|
|
Change in cognitive function - sustained attention at 3 months
Time Frame: Change from baseline 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
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)
|
Change from baseline at 3 months
|
|
Change in sleep quality at 3 months
Time Frame: Change from baseline 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
Time Frame: Change from baseline to 3 months
|
Assessment of mood using the Affect Grid
|
Change from baseline to 3 months
|
|
Change in perceived stress over 3 months
Time Frame: Change from baseline at 3 months
|
Assessment of stress using the Perceived Stress Scale (PSS-10)
|
Change from baseline at 3 months
|
|
Change in anxiety at 3 months
Time Frame: Change from baseline 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
Time Frame: Change from baseline 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
Time Frame: Change from baseline at 3 months
|
Acute phase inflammatory response measured by hsCRP
|
Change from baseline at 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2340870
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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