Recruiting

Dietary Intervention

Sponsor:

University of Maryland, Baltimore

Code:

NCT05977179

Conditions

Post-Acute COVID-19 Syndrome

Fatigue

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Dietary intervention to mitigate Post-Acute COVID-19 Syndrome

Attention Control

Study Details

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. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS?
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?

At the beginning of the study, eligible participants will be randomly assigned to either the Dietary Intervention Group, where they will receive personalized dietary plans and weekly sessions, or the Attention Control Group, where they will attend general health sessions on a weekly basis as well.

This research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes of the two groups, we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS.

Conditions

Post-Acute COVID-19 Syndrome

Fatigue

Study ID

NCT05977179

Start date

May 12, 2025

Status verified date

Jun, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Participants with a home oxygen requirement or requiring chronic ventilator support
2. Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c > 9%
3. Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) > class 2
4. Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.
5. 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.
6. Participants diagnosed with uncontrolled hypertension that will be defined as:

1. Systolic blood pressure consistently equal to or higher than 190 mmHg.
2. Diastolic blood pressure consistently equal to or higher than 110 mmHg.
3. Participants with a recent history of hypertensive crisis (severe elevation in blood pressure requiring immediate medical intervention), regardless of current blood pressure levels.
7. Participants with diet restrictions or allergies that can affect adherence to the diet, such as allergy to fish or shellfish.
8. Participation in another trial in which active intervention is being received.
9. Participants with active drug or alcohol use/dependence that would interfere with adherence to the study.
10. Participants scheduled for surgical procedures within the next 6 months.
11. Participants diagnosed with active cancer.
12. Participants diagnosed with liver diseases.
13. Participants diagnosed with kidney-related conditions, including Chronic Kidney Disease (CKD) > stage 3.
14. Below the age of 50 years.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

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: Attention Control

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.

Interventions

Dietary intervention to mitigate Post-Acute COVID-19 Syndrome

As it was described in the arm/group descriptions.

Attention Control

As it was described in the arm/group descriptions.

Primary outcome measure

  • Fatigue [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial) ]
  • Physical Function [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial) ]

Central Contacts and Locations

Central contacts

Galya Bigman, PhD

4109168191gbigman@som.umaryland.edu

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • COVID
  • long-COVID
  • DIET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-06-23.