Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT07227259
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2025-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Properties of Pecan Nut Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-09', 'studyFirstSubmitDate': '2025-11-09', 'studyFirstSubmitQcDate': '2025-11-09', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vascular response at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Vascular response as measured by Pulse Wave Velocity (PWV)'}], 'secondaryOutcomes': [{'measure': 'Change in blood lipids over 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Blood lipids as measured by clinical lipid panel, including total, LDL and HDL cholesterol, and Tiglycerides'}, {'measure': 'Change in markers of inflammation at 3 months', 'timeFrame': 'change from baseline at 3 months', 'description': 'Markers of inflammation as measured by Luminex cytokine panel IL-17'}, {'measure': 'Change in gut microbiome profile at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Gut microbiome profile as measured by fecal 16S rRNA gene sequencing'}, {'measure': 'Change in blood markers of intestinal permeability at 3 months.', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Blood marker of intestinal permeability as measured by ELISA for LBP and LPS'}, {'measure': 'Change in blood markers of intestinal permeability at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Blood biomarker of intestinal permeability and immune activation as measured by ELISA of sCD14'}, {'measure': 'Change in cognitive function - reaction time at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Reaction time task as measured by CANTAB assessments'}, {'measure': 'Change in cognitive function - working memory at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Spatial working memory as assessed by CANTAB'}, {'measure': 'Change in cognitive function - episodic memory at 3 months', 'timeFrame': 'Change from baseline to 3 months', 'description': 'Paired associates learning as measured by CANTAB'}, {'measure': 'Change in cognitive function - sustained attention at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Attention measured via Rapid visual information processing using CANTAB'}, {'measure': 'Change in quality of life at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Self-perceived quality of life questionnaire assessed using World Health Organization Qualigy of Life Instruments (WHOQOL-BREF)'}, {'measure': 'Change in sleep quality at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Self-rated questionnaire of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Change in mood over 3 months', 'timeFrame': 'Change from baseline to 3 months', 'description': 'Assessment of mood using the Affect Grid'}, {'measure': 'Change in perceived stress over 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Assessment of stress using the Perceived Stress Scale (PSS-10)'}, {'measure': 'Change in anxiety at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Anxiety measured using the Generalized Anxiety disorder Scale (GAD-7)'}, {'measure': 'Change in depressive symptoms at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Assessment of depressive symptoms using the Beck Depression Inventory-II (BDI-II)'}, {'measure': 'Change in blood acute phase inflammatory response maker at 3 months', 'timeFrame': 'Change from baseline at 3 months', 'description': 'Acute phase inflammatory response measured by hsCRP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pecan nut', 'cardiovascular', 'gut microbiome', 'cognitive'], 'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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) -\n\nExclusion 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.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07227259', 'briefTitle': 'Health Properties of Pecan Nut Consumption', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Assessment of Systematic Health Properties of Pecan Nut Consumption: Gut, Vascular, Metabolic and Cognitive Outcomes', 'orgStudyIdInfo': {'id': '2340870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pecan nut then no nut', 'description': 'Participant will add pecan nuts to their diet during the first intervention arm, then they will cross over to the no nut diet arm', 'interventionNames': ['Other: pecan nut']}, {'type': 'EXPERIMENTAL', 'label': 'No nut then pecan nut', 'description': '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.', 'interventionNames': ['Other: pecan nut']}], 'interventions': [{'name': 'pecan nut', 'type': 'OTHER', 'description': 'Dose - 2 ounces of pecan nuts, daily', 'armGroupLabels': ['No nut then pecan nut', 'Pecan nut then no nut']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francene Steinberg, PhD', 'role': 'CONTACT', 'email': 'fmsteinberg@ucdavis.edu', 'phone': '530-752-0160'}], 'facility': 'Ragle Human Nutrition Center, UC Davis campus', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'centralContacts': [{'name': 'Francene Steinberg, PhD', 'role': 'CONTACT', 'email': 'fmsteinberg@ucdavis.edu', 'phone': '530-752-0160'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Francene Steinberg', 'investigatorAffiliation': 'University of California, Davis'}}}}