Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:16 AM
Study NCT ID:
NCT07429903
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Daily Walnut Consumption on Memory in Subjects With Long-COVID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D005222', 'term': 'Mental Fatigue'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Episodic Memory - RAVLT-Revised Long-Delay Free Recall (number of words recalled)', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in long-delay free recall score (number of words correctly recalled) on the RAVLT-Revised from baseline to week 12.'}], 'secondaryOutcomes': [{'measure': 'Executive Function', 'timeFrame': 'Baseline to Week 12', 'description': 'Digit Vigilance Test Score Description: Total completion time (seconds) and/or number of errors on the Digit Vigilance Test, assessing sustained attention and processing speed.'}, {'measure': 'Trail Making Test Part A Completion Time', 'timeFrame': 'baseline and 12 weeks', 'description': 'Description: Time to completion (seconds) for Trail Making Test Part A, assessing processing speed.'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline and 12', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue Short Form - 8 Item.\n\nFatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue Short Form (8 items). Raw scores range from 8 to 40, with higher scores indicating greater fatigue (worse outcome). Scores may also be converted to standardized T-scores (mean = 50, SD = 10), where higher T-scores indicate greater fatigue.'}, {'measure': 'Mood', 'timeFrame': 'baseline and 12 weeks', 'description': 'PROMIS® Depression Short Form (8 items)'}, {'measure': 'NIH Toolbox Cognitive Battery (NIHTB-CB) - Fluid Intelligence Composite', 'timeFrame': 'Baseline to Week 12', 'description': 'Fluid cognitive function will be assessed using the Fluid Intelligence Composite score from the NIH Toolbox Cognitive Battery. The composite is a standardized score (mean = 100, SD = 15), with higher scores indicating better cognitive performance.'}, {'measure': 'Quality of Life', 'timeFrame': 'Baseline and 12', 'description': 'SF-36 Health Survey'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline and Week 12', 'description': 'Seated systolic and diastolic blood pressure\n\nSystolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) using an automated calibrated sphygmomanometer after 5 minutes of seated rest. Higher values indicate higher blood pressure.'}, {'measure': 'Dietary Intake', 'timeFrame': 'Baseline and 12', 'description': '24-hour dietary recall (ASA24™)'}, {'measure': 'Blood and Urine Biomarkers', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'Measures:\n\nmetabolic markers and inflammatory Blood fatty acid profile Plasma ellagic acid Urinary urolithin metabolites (LC-MS/MS)'}, {'measure': 'WAIS-IV Symbol Search Score', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Total correct responses (scaled score) on the WAIS-IV Symbol Search subtest, assessing processing speed.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline and Week 12', 'description': 'Resting heart rate\n\nDescription:\n\nResting heart rate will be measured in beats per minute (bpm) using an automated blood pressure monitor after 5 minutes of seated rest.'}, {'measure': 'Body Weight', 'timeFrame': 'baseline and week 12', 'description': 'Measure:\n\nBody weight in kilograms\n\nDescription:\n\nBody weight will be measured in kilograms (kg) using a calibrated digital scale with participants wearing light clothing and no shoes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long-COVID', 'Brain Fog', 'Cognition', 'Memory']}, 'descriptionModule': {'briefSummary': 'Approximately 30% of patients experience "Long-COVID" syndrome presenting with symptoms such as cognitive difficulties (\'brain fog\'), fatigue, dyspnea, autonomic dysfunction, depression and anxiety, lasting beyond 12 weeks causing significant disability, and threaten health and wellbeing of millions around the world. At the current time, there is no effective treatment for long-COVID. Walnuts contain a mixture of nutrients and phytochemicals include monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), and alpha-linolenic acid (ALA). Walnut consumption was directly associated with cognitive function. The investigators have shown pomegranate that share the same phytonutrient ellagitannins as walnut and mixed nuts including walnuts could increase blood microbiome metabolites of tryptophan metabolite indole propionate and serotonin levels via change of gut microbiota and therefore play an essential role in gut-brain axis including cognitive function. The proposed pilot study will include 76 adults (ages \\>40 years) with diagnosis of SARS-CoV2 infection presenting with long-COVID symptoms lasting longer than 12 weeks. They will be randomized 1:1 to usual care vs. an intervention group that will include 2 oz (57g) of walnuts daily into their habitual diet for 12 weeks. The investigators will compare the improvement in symptoms of cognitive complains of "brain fog", fatigue and depression of the active intervention group vs. usual care. The outcome of the investigation of the benefit of walnut consumption will provide important novel information on using dietary sources of polyunsaturated fatty acids and phytochemicals to mitigate the common symptoms of long-COVID. This application was submitted in response to the California Walnut Commission\'s commodity board topic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 40 years and older\n\nHistory of confirmed SARS-CoV-2 infection\n\nPresence of long-COVID symptoms lasting longer than 12 weeks, including one or more of the following:\n\n* Cognitive complaints ("brain fog," memory, attention, or processing speed difficulties)\n* Fatigue\n* Mood symptoms (e.g., depression)\n\nConsumption of a low-polyphenol (Western) diet\n\nAdequate visual acuity and hearing to complete neuropsychological testing\n\nScreening laboratory results without clinically significant abnormalities that would interfere with study participation\n\nAbility and willingness to provide written informed consent\n\nExclusion Criteria:\n\nDiagnosis of probable Alzheimer\'s disease or other dementia (e.g., vascular, Lewy body, frontotemporal)\n\nOther neurological or medical conditions that may cause cognitive impairment\n\nEvidence of Parkinson\'s disease based on motor examination\n\nUncontrolled hypertension (systolic BP \\>170 mmHg or diastolic BP \\>100 mmHg)\n\nAllergy to walnuts\n\nRegular consumption of more than 5 oz of walnuts per week\n\nCurrent diagnosis of a major psychiatric disorder according to DSM-5 criteria\n\nAlcoholism or substance use disorder\n\nAny condition that, in the investigator\'s judgment, would make participation unsafe or interfere with study completion'}, 'identificationModule': {'nctId': 'NCT07429903', 'briefTitle': 'Effect of Daily Walnut Consumption on Memory in Subjects With Long-COVID', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Effect of Daily Walnut Consumption on Memory in Subjects With Long-COVID', 'orgStudyIdInfo': {'id': '23-000654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walnuts', 'interventionNames': ['Other: whole food - walnuts']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Habitual diet while avoiding nuts'}], 'interventions': [{'name': 'whole food - walnuts', 'type': 'OTHER', 'description': 'Participants randomized to the intervention group will consume (2 oz ) of whole walnuts daily, incorporated into their diet for 12 weeks. Walnuts were provided to participants, and adherence was monitored using dietary records.', 'armGroupLabels': ['Walnuts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Center for Human Nutrition', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles', 'investigatorFullName': 'Zhaoping Li', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}