Actively Recruiting

Phase Not Applicable
Age: 50Years - 94Years
All Genders
NCT05977179

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

Age: 50Years - 94Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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