Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-94
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary intervention to mitigate Post-Acute COVID-19 Syndrome
Other interventionAs it was described in the arm/group descriptions.
Attention Control
Other interventionAs it was described in the arm/group descriptions.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Dietary intervention to mitigate Post-Acute COVID-19 SyndromeExperimental treatment 1 intervention
Group B: Attention ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Fatigue
Fatigue will be assessed by the brief fatigue inventory (BFI)
Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)2
Physical Function
Physical Function will be measured by the Short Physical Performance Battery(SPPB)
Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)Sponsors and contacts
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Source ClinicalTrials.gov