Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome

NCT05977179 | Recruiting DMC

• 1 other identifier: HP-00106745
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older. The main research questions this study aims to answer are:

1. 1.Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS?
2. 2.Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate declines in muscle function and physical performance in adults with PACS?

Conditions

Post-Acute COVID-19 Syndrome; Fatigue

Keywords

COVID; long-COVID; DIET

Outcome Measures

Primary Outcomes (2)

• Fatigue

  Fatigue will be assessed by the brief fatigue inventory (BFI)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)

• Physical Function

  Physical Function will be measured by the Short Physical Performance Battery(SPPB)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)

Study Arms (2)

Dietary intervention to mitigate Post-Acute COVID-19 Syndrome

EXPERIMENTAL

During the intervention, participants will receive an individual dietary plan from a Registered Dietitian (RD) that emphasizes nutrients with high anti-inflammatory activity, which can be obtained from various foods and supplements (e.g., vitamin D, omega-3, and quality protein). Additionally, participants will actively participate in weekly dietary sessions that cover topics from 'What's On Your Plate?', specifically tailored to address the nutrition recommendations for older adults in the Dietary Guidelines for Americans 2020-2025.

Other: Dietary intervention to mitigate Post-Acute COVID-19 Syndrome

Attention Control

OTHER

Participants in the control group will receive an equal amount of social attention, in terms of both dose and duration, comparable to that provided in the intervention group. Topics covered during these sessions will focus on healthy aging, including oral health, hearing loss, eyesight, and ensuring a safe environment by addressing issues such as gas leaks, fire hazards, and fall prevention. No dietary information will be included in these discussions.

Other: Attention Control

Interventions

Dietary intervention to mitigate Post-Acute COVID-19 Syndrome OTHER

As it was described in the arm/group descriptions.

Dietary intervention to mitigate Post-Acute COVID-19 Syndrome

Attention Control OTHER

As it was described in the arm/group descriptions.

Attention Control

Eligibility Criteria

• Age: 50 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 50 years or older
• No known active infectious disease (COVID-19 or other).
• Participant diagnosed with long-COVID/ post- acute COVID-19 syndrome (PACS) /ICD-10-CM codes U09.9
• Moderate/severe fatigue Brief Fatigue Inventory (BFI)≥4
• Poor diet quality assessed by the short Healthy Eating Index (HEI)\<70

You may not qualify if:

• Participants with a home oxygen requirement or requiring chronic ventilator support
• Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c \> 9%
• Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) \> class 2
• Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.
• Evidence of any condition as determined by a physician or the study team that would lead to an increased risk of illness due to any aspect of proposed testing and interventions, or introduce unanticipated confounding of study results.
• Participants diagnosed with uncontrolled hypertension that will be defined as:
• Systolic blood pressure consistently equal to or higher than 190 mmHg.
• Diastolic blood pressure consistently equal to or higher than 110 mmHg.
• Participants with a recent history of hypertensive crisis (severe elevation in blood pressure requiring immediate medical intervention), regardless of current blood pressure levels.
• Participants with diet restrictions or allergies that can affect adherence to the diet, such as allergy to fish or shellfish.
• Participation in another trial in which active intervention is being received.
• Participants with active drug or alcohol use/dependence that would interfere with adherence to the study.
• Participants scheduled for surgical procedures within the next 6 months.
• Participants diagnosed with active cancer.
• Participants diagnosed with liver diseases.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Galya Bigman, PhD

CONTACT

5125763823; gbigman@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Maryland, School of Medicine, Baltimore, MD

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: May 12, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)