Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome
United States56 participantsStarted 2025-05-12
Plain-language 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 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.
Who can participate
Age range
50 Years – 94 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age of 50 years or older
. No known active infectious disease (COVID-19 or other).
. Poor diet quality assessed by the short Healthy Eating Index (HEI)\<70
Exclusion criteria
. Participants with a home oxygen requirement or requiring chronic ventilator support
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a dietary intervention for post-acute COVID-19 syndrome — can you help me understand what kind of dietary changes are involved, and whether there's any existing evidence they might help with my fatigue or physical function?
2Since this trial is listed as Phase NA, which often means it's studying a non-drug intervention like diet, what do we know about how safe and well-studied this approach is compared to other options I might have for long COVID symptoms?
3The trial is measuring fatigue and physical function as its main outcomes — given where I am right now with those specific symptoms, do you think I'm a realistic candidate to discuss with the research team, or should I try other approaches first?
4How demanding would participating in a dietary intervention study likely be in terms of follow-up visits, food tracking, or changes to my eating habits, and is that realistic given how my long COVID symptoms are affecting my daily life?
5Are there standard-of-care treatments or other clinical trials for post-acute COVID-19 syndrome that you think I should weigh against this dietary study before deciding whether to reach out to the research team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
2
Physical Function
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks (end of the trial)
. 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.