Actively Recruiting
A Diet Intervention Study To Mitigate Fatigue Symptoms And To Improve Muscle And Physical Function In Older Adults With Post-Acute COVID-19 Syndrome
Led by University of Maryland, Baltimore · Updated on 2025-07-11
56
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of a Whole-Diet Approach based on a healthy US-style diet rich in anti-inflammatory properties on reducing symptoms of Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older. The study aims to evaluate whether this diet can lessen fatigue and improve muscle function and physical performance in this population during a 16-week randomized controlled trial. Participants will be randomly assigned to one of two groups. The Dietary Intervention Group will receive a personalized diet plan from a Registered Dietitian focused on nutrients with anti-inflammatory effects and participate in weekly group sessions to support diet adherence. The Attention Control Group will attend weekly sessions on general health topics related to healthy aging and safety but will not receive dietary guidance. Both groups will follow their assigned plans throughout the 16-week period. During the trial, participants will be assessed regularly for fatigue levels and physical function at baseline and every four weeks until the study ends at 16 weeks. The team will monitor diet adherence and collect data to compare the effects of the dietary intervention against the control. This research seeks to provide insights into how a targeted diet may help older adults manage PACS symptoms and improve their overall well-being.
CONDITIONS
Brief 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
- Diagnosed with long-COVID/post-acute COVID-19 syndrome (PACS) with ICD-10-CM code U09.9
- Moderate to severe fatigue with Brief Fatigue Inventory score of 4 or higher
- Poor diet quality with a short Healthy Eating Index score below 70
- No known active infectious disease such as COVID-19 or other infections
You will not qualify if you...
- Requirement for home oxygen or chronic ventilator support
- Diabetes without recent HbA1c or HbA1c greater than 9%
- Congestive Heart Failure above New York Heart Association class 2
- Dietary restrictions due to medications affecting blood clotting like Warfarin
- Any condition increasing risk or confounding study results as determined by physician or study team
- Uncontrolled hypertension (systolic ≥190 mmHg, diastolic ≥110 mmHg, or recent hypertensive crisis)
- Allergies affecting diet adherence such as fish or shellfish allergy
- Participation in another trial with active intervention
- Active drug or alcohol use/dependence interfering with study adherence
- Scheduled for surgery within 6 months
- Active cancer diagnosis
- Liver diseases
- Kidney conditions including Chronic Kidney Disease stage greater than 3
- Under 50 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants follow a 16-week dietary intervention or attend educational sessions, depending on their assigned group. Those in the dietary intervention group receive a personalized diet plan and weekly group sessions with a Registered Dietitian. The control group attends weekly educational sessions on healthy aging and safety without dietary information.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 1 location
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
G
Galya Bigman, PhD
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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