Dietary intervention to reduce symptoms of long COVID

A Diet Intervention Study To Mitigate Fatigue Symptoms And To Improve Muscle And Physical Function In Older Adults With Post-Acute COVID-19 Syndrome

This study is testing if a special diet can help adults aged 50 and older with long COVID feel less tired and improve their muscle strength.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 50 Years to 94 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05977179 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a Whole-Diet Approach over 16 weeks to alleviate symptoms of Post-Acute COVID-19 Syndrome (PACS) in adults aged 50 and older. Participants will be randomly assigned to either a Dietary Intervention Group, receiving personalized dietary plans and weekly sessions with a Registered Dietitian, or an Attention Control Group, attending general health education sessions without specific dietary guidance. The primary focus is on reducing fatigue and improving muscle function through a diet rich in anti-inflammatory properties. The study aims to provide insights into dietary impacts on long COVID symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 years or older diagnosed with Post-Acute COVID-19 Syndrome and experiencing moderate to severe fatigue.

Not a fit: Patients with severe underlying health conditions, such as those requiring chronic ventilator support or with poorly controlled diabetes, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from long COVID by reducing fatigue and enhancing physical performance.

How similar studies have performed: While dietary interventions for chronic conditions have shown promise, this specific approach targeting long COVID symptoms is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Baltimore, Maryland

• University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Galya Bigman, PhD

Conditions Post-Acute COVID-19 Syndrome; Fatigue; COVID; long-COVID; DIET