Dietary Intervention for Long COVID Syndrome

(Long-COVIDiet Trial)

Overseen By Alice Ryan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Warfarin

Disqualifiers: Diabetes, CHF, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a healthy, anti-inflammatory diet might reduce symptoms of long COVID in adults over 50. Participants will either follow a personalized diet plan or attend general health sessions on topics such as aging and safety. The study aims to determine if this diet can lessen fatigue and improve muscle function and physical performance. It suits those with long COVID who experience moderate to severe fatigue and recognize poor diet quality. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of dietary changes for long COVID symptoms.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on medications that affect blood clotting, like Warfarin, you may not be eligible to participate.

What prior data suggests that this dietary intervention is safe for adults with PACS?

Research shows that a healthy US-style diet with anti-inflammatory nutrients might be safe and helpful for people with long COVID. Studies have found that nutrients like omega-3 fatty acids, certain vitamins, and quality proteins can help lower inflammation in the body. This decrease in inflammation might help relieve some long COVID symptoms.

The diet in this study follows the Dietary Guidelines for Americans, which are well-known and widely used throughout the United States. These guidelines emphasize balance and variety, encouraging plenty of fruits, vegetables, lean proteins, and healthy fats. Most people generally find these foods safe and well-tolerated.

While researchers continue to study this specific diet for its effects on long COVID symptoms, its components have been safely used in other situations. People considering this diet can feel confident about the safety of these dietary elements based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for Long COVID, which often focus on symptom management with medications, dietary intervention offers a holistic approach by emphasizing nutrients with high anti-inflammatory properties. This intervention, led by a Registered Dietitian, aims to reduce inflammation through a personalized diet rich in vitamin D, omega-3s, and quality protein. Researchers are excited because this method targets the root cause of lingering symptoms rather than just alleviating them, potentially leading to more comprehensive and lasting relief for patients.

What evidence suggests that this dietary intervention is effective for mitigating Post-Acute COVID-19 Syndrome?

This trial will compare a dietary intervention with an attention control group to assess the impact on Long COVID symptoms. Research has shown that a healthy diet with anti-inflammatory foods might ease Long COVID symptoms. Studies have found that nutrients like vitamin D, omega-3 fatty acids, and high-quality protein can lower inflammation and boost overall health. Specifically, early findings suggest these nutrients may reduce tiredness and improve muscle strength in people with Long COVID. A review also highlights that diet and nutrition can aid recovery by reducing inflammation and supporting gut health. While more research is needed, these early results offer promise for those experiencing Post-Acute COVID-19 symptoms. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 50 or older who have been diagnosed with long-COVID/post-acute COVID-19 syndrome and are experiencing moderate to severe fatigue. They should not have any active infectious diseases and must typically consume a poor diet as assessed by the Healthy Eating Index.

Inclusion Criteria

You have an inadequate diet quality based on the evaluated scores of your short Healthy Eating Index (HEI).

I am 50 years old or older.

I do not have COVID-19 or any other active infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants receive a personalized dietary plan and attend weekly sessions focusing on a healthy US-style diet rich in anti-inflammatory properties

16 weeks

16 visits (in-person or virtual)

Attention Control

Participants attend weekly educational sessions on general health topics without specific dietary information

16 weeks

16 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome

Trial Overview The study tests if a healthy US-style diet rich in anti-inflammatory foods can reduce fatigue and improve muscle function in those with Post-Acute Sequelae of SARS-CoV-2 Infection (PACS). Participants will either receive personalized dietary plans or attend general health sessions for comparison.

How Is the Trial Designed?

Group I: Dietary intervention to mitigate Post-Acute COVID-19 Syndrome Experimental Treatment 1 Intervention

During the intervention, participants will receive an individual dietary plan from a Registered Dietitian (RD) that emphasizes nutrients with high anti-inflammatory activity, which can be obtained from various foods and supplements (e.g., vitamin D, omega-3, and quality protein). Additionally, participants will actively participate in weekly dietary sessions that cover topics from 'What's On Your Plate?', specifically tailored to address the nutrition recommendations for older adults in the Dietary Guidelines for Americans 2020-2025.

Group II: Attention Control Experimental Treatment 1 Intervention

Participants in the control group will receive an equal amount of social attention, in terms of both dose and duration, comparable to that provided in the intervention group. Topics covered during these sessions will focus on healthy aging, including oral health, hearing loss, eyesight, and ensuring a safe environment by addressing issues such as gas leaks, fire hazards, and fall prevention. No dietary information will be included in these discussions.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

This systematic scoping review identified five studies exploring nutritional interventions for long COVID, highlighting the potential benefits of nutrients like B vitamins, vitamin C, vitamin D, and acetyl-l-carnitine, particularly in rehabilitation settings.

While initial reports on nutritional supplements showed positive outcomes, the studies were poorly designed, indicating a need for more rigorous clinical trials to establish effective dietary interventions for long COVID symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Support During Long COVID: A Systematic Scoping Review. Bradbury, J., Wilkinson, S., Schloss, J.[2023]

Nearly half of the 92 participants recovering from COVID-19 were at risk for malnutrition, which was linked to more severe symptoms and lower calorie intake, indicating that persistent malnutrition can hinder recovery.

Most participants failed to meet dietary recommendations for fruits, vegetables, and optimal protein intake, suggesting a critical need for nutritional education and support to improve recovery outcomes after COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of COVID-19 Infection and Persistent Lingering Symptoms on Patient Reported Indicators of Nutritional Risk and Malnutrition. Deer, RR., Hosein, E., Harvey, M., et al.[2022]

Post-COVID-19 syndrome can lead to malnutrition, loss of muscle mass, and low-grade inflammation, highlighting the need for comprehensive health evaluations for COVID-19 survivors.

Personalized dietary recommendations are crucial for recovery, as they can help address persistent symptoms like fatigue, appetite loss, and psychological distress in patients recovering from COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Recommendations for Post-COVID-19 Syndrome. Barrea, L., Grant, WB., Frias-Toral, E., et al.[2022]

A 2-month nutritional intervention using a high-fiber formula significantly alleviated gastrointestinal symptoms in a patient with post-acute COVID-19 syndrome, leading to improvements in appetite, anxiety, and medication dosage for nausea.

The intervention resulted in beneficial changes in the patient's gut microbiota, including the increase of short-chain fatty acid-producing bacteria, which may be linked to symptom relief, highlighting the potential of gut microbiota modulation as a therapeutic strategy for post-COVID-19 gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Modulation of Gut Microbiota Alleviates Severe Gastrointestinal Symptoms in a Patient with Post-Acute COVID-19 Syndrome. Wang, Y., Wu, G., Zhao, L., et al.[2022]

In a study of 41 adults with COVID-19, significant differences in plasma fatty acid profiles were found between those with moderate or severe disease and those with mild or no infection, suggesting that fatty acids may play a role in disease severity.

Lower levels of certain unsaturated fatty acids, like γ-linolenic acid and eicosapentaenoic acid, were linked to the development of post-acute sequelae of COVID-19 (PASC), indicating that dietary fatty acids could be potential targets for improving recovery and preventing long-term symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between plasma fatty acids in adults with mild, moderate, or severe COVID-19 and the development of post-acute sequelae. Stromberg, S., Baxter, BA., Dooley, G., et al.[2023]

The COVID-19 pandemic disproportionately affects the elderly, underrepresented minorities, and individuals with underlying health conditions, with unhealthy diets high in saturated fats and sugars increasing their risk for severe outcomes.

Consumption of a Western diet activates the innate immune system and leads to chronic inflammation, which can impair the body's ability to fight off viruses like COVID-19 and may result in long-term health issues such as dementia after recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of nutrition on COVID-19 susceptibility and long-term consequences. Butler, MJ., Barrientos, RM.[2021]

Citations

1. umaryland.trialstoday.org umaryland.trialstoday.org/trial/NCT05977179

Dietary Intervention to Mitigate Post-Acute COVID-19 ... The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole- ...

2. reporter.nih.gov reporter.nih.gov/project-details/11164711

A Diet Intervention Study To Mitigate Fatigue Symptoms ... This project proposes to examine, in a 16-week randomized-controlled dietary intervention, the effect of the 'Whole- Diet Approach' on mitigating symptoms of ...

3. withpower.com withpower.com/trial/phase-covid-19-9-2023-35410

Dietary Intervention for Long COVID Syndrome Trial Overview The study tests if a healthy US-style diet rich in anti-inflammatory foods can reduce fatigue and improve muscle function in those with Post- ...

4. clinicaltrial.be clinicaltrial.be/en/details/459215?per_page=100&condition[0]=PASC%20Post%20Acute%20Sequelae%20of%20COVID%2019&condition[1]=Long%20COVID&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Dietary Intervention to Mitigate Post-Acute COVID-19 Synd... The main objective of this research is to evaluate the impact of the 'Whole-Diet Approach' through a 16-week randomized-controlled dietary ...

5. mdpi.com mdpi.com/2072-6643/17/11/1802

A Comprehensive Scoping Review on Diet and Nutrition in ... Conclusions: Diet and nutrition may support long COVID-19 recovery by targeting inflammation and the gut microbiome to alleviate symptoms and improve functional ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625001027

Impact of nutrition on long COVID Effective interventions like supplementation of omega-3 fatty acid, macro and micro nutrients, and vitamins help to reduce systemic inflammation ...