RECRUITING

Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome

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Conditions

Post-Acute COVID-19 SyndromeFatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-14
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05977179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 94 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age of 50 years or older
  2. 2. No known active infectious disease (COVID-19 or other).
  3. 3. Participant diagnosed with long-COVID/ post- acute COVID-19 syndrome (PACS) /ICD-10-CM codes U09.9
  4. 4. Moderate/severe fatigue Brief Fatigue Inventory (BFI)≥4
  5. 5. Poor diet quality assessed by the short Healthy Eating Index (HEI)\<70
  1. 1. Participants with a home oxygen requirement or requiring chronic ventilator support
  2. 2. Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c \> 9%
  3. 3. Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) \> class 2
  4. 4. Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.
  5. 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. 6. Participants diagnosed with uncontrolled hypertension that will be defined as:
  7. 1. Systolic blood pressure consistently equal to or higher than 190 mmHg.
  8. 2. Diastolic blood pressure consistently equal to or higher than 110 mmHg.
  9. 3. Participants with a recent history of hypertensive crisis (severe elevation in blood pressure requiring immediate medical intervention), regardless of current blood pressure levels.
  10. 7. Participants with diet restrictions or allergies that can affect adherence to the diet, such as allergy to fish or shellfish.
  11. 8. Participation in another trial in which active intervention is being received.
  12. 9. Participants with active drug or alcohol use/dependence that would interfere with adherence to the study.
  13. 10. Participants scheduled for surgical procedures within the next 6 months.
  14. 11. Participants diagnosed with active cancer.
  15. 12. Participants diagnosed with liver diseases.
  16. 13. Participants diagnosed with kidney-related conditions, including Chronic Kidney Disease (CKD) \> stage 3.
  17. 14. Below the age of 50 years.

Contacts and Locations

Study Contact

Galya Bigman, PhD
CONTACT
5125763823
gbigman@som.umaryland.edu
Alice Ryan, PhD
CONTACT
aryan@som.umaryland.edu

Study Locations (Sites)

University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-14
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-11-14
Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Post-Acute COVID-19 Syndrome
  • Fatigue