Actively Recruiting
Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
Led by University of Maryland, Baltimore · Updated on 2025-07-11
56
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 50 years or older
- No known active infectious disease (COVID-19 or other)
- Diagnosed with long-COVID/Post-Acute COVID-19 Syndrome (PACS) with ICD-10-CM code U09.9
- Moderate to severe fatigue with a Brief Fatigue Inventory score of 4 or higher
- Poor diet quality with a Healthy Eating Index score below 70
You will not qualify if you...
- Requires home oxygen or chronic ventilator support
- Diabetes without recent HbA1c or with HbA1c greater than 9%
- Congestive Heart Failure New York Heart Association class greater than 2
- Dietary restrictions due to medications affecting blood clotting, such as Warfarin
- Conditions increasing risk of illness or confounding study results as determined by physician or study team
- Uncontrolled hypertension defined by systolic blood pressure ≥ 190 mmHg, diastolic blood pressure ≥ 110 mmHg, or recent hypertensive crisis
- Diet restrictions or allergies affecting adherence, such as fish or shellfish allergy
- Participation in another active intervention trial
- Active drug or alcohol use/dependence interfering with study adherence
- Scheduled for surgical procedures within the next 6 months
- Active cancer diagnosis
- Liver diseases
- Kidney conditions including Chronic Kidney Disease stage greater than 3
- Age below 50 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
G
Galya Bigman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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