Status:
RECRUITING
Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Post-Acute COVID-19 Syndrome
Fatigue
Eligibility:
All Genders
50-94 years
Phase:
NA
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 ...
Detailed Description
The main objective of this research is to evaluate the impact of the 'Whole-Diet Approach' through a 16-week randomized-controlled dietary intervention on reducing symptoms of PACS (Post-Acute Sequela...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Participants diagnosed with kidney-related conditions, including Chronic Kidney Disease (CKD) \> stage 3.
- Below the age of 50 years.
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05977179
Start Date
May 12 2025
End Date
September 30 2028
Last Update
July 11 2025
Active Locations (1)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201