NCT07429903

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 23, 2026

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Episodic Memory - RAVLT-Revised Long-Delay Free Recall (number of words recalled)

    Change in long-delay free recall score (number of words correctly recalled) on the RAVLT-Revised from baseline to week 12.

    Baseline to Week 12

Secondary Outcomes (12)

  • Executive Function

    Baseline to Week 12

  • Trail Making Test Part A Completion Time

    baseline and 12 weeks

  • Fatigue

    Baseline and 12

  • Mood

    baseline and 12 weeks

  • NIH Toolbox Cognitive Battery (NIHTB-CB) - Fluid Intelligence Composite

    Baseline to Week 12

  • +7 more secondary outcomes

Study Arms (2)

Walnuts

EXPERIMENTAL
Other: whole food - walnuts

Control

NO INTERVENTION

Habitual diet while avoiding nuts

Interventions

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.

Walnuts

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 years and older
  • History of confirmed SARS-CoV-2 infection
  • Presence of long-COVID symptoms lasting longer than 12 weeks, including one or more of the following:
  • Cognitive complaints ("brain fog," memory, attention, or processing speed difficulties)
  • Fatigue
  • Mood symptoms (e.g., depression)
  • Consumption of a low-polyphenol (Western) diet
  • Adequate visual acuity and hearing to complete neuropsychological testing
  • Screening laboratory results without clinically significant abnormalities that would interfere with study participation
  • Ability and willingness to provide written informed consent

You may not qualify if:

  • Diagnosis of probable Alzheimer's disease or other dementia (e.g., vascular, Lewy body, frontotemporal)
  • Other neurological or medical conditions that may cause cognitive impairment
  • Evidence of Parkinson's disease based on motor examination
  • Uncontrolled hypertension (systolic BP \>170 mmHg or diastolic BP \>100 mmHg)
  • Allergy to walnuts
  • Regular consumption of more than 5 oz of walnuts per week
  • Current diagnosis of a major psychiatric disorder according to DSM-5 criteria
  • Alcoholism or substance use disorder
  • Any condition that, in the investigator's judgment, would make participation unsafe or interfere with study completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeMental Fatigue

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFatigueSigns and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 24, 2026

Study Start

September 21, 2023

Primary Completion

January 24, 2025

Study Completion

January 24, 2025

Last Updated

February 24, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations