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

Trial Summary

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 data supports the effectiveness of the dietary intervention treatment for Long COVID Syndrome?

Research suggests that nutritional interventions, such as a high-fiber diet, can help alleviate symptoms of Long COVID by improving gut health and reducing inflammation. Additionally, many patients with Long COVID experience malnutrition, and a balanced diet rich in fruits, vegetables, and adequate protein may support recovery and reduce lingering symptoms. ^{1 2 3 4 5}

Is the dietary intervention for Long COVID safe for humans?

The dietary intervention, which includes a high-fiber formula and nutritional supplements, has been used in studies without reported safety issues, suggesting it is generally safe for humans. However, more research is needed to confirm its safety and effectiveness for Long COVID specifically. ^{1 2 3 4 6}

How is the dietary intervention treatment for Long COVID different from other treatments?

The dietary intervention for Long COVID focuses on a whole-diet approach, emphasizing a balanced intake of nutrients like proteins, fruits, and vegetables, which is different from other treatments that may focus on specific supplements or medications. This approach aims to address malnutrition and inflammation, which are common in Long COVID, by promoting overall healthy eating habits rather than targeting individual symptoms with specific drugs or supplements. ^{1 2 3 4 6}

What is the purpose of 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of COVID-19 Infection and Persistent Lingering Symptoms on Patient Reported Indicators of Nutritional Risk and Malnutrition. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Nutritional Modulation of Gut Microbiota Alleviates Severe Gastrointestinal Symptoms in a Patient with Post-Acute COVID-19 Syndrome. [2022]

3. Switzerland 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Nutritional Support During Long COVID: A Systematic Scoping Review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Recommendations for Post-COVID-19 Syndrome. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of nutrition on COVID-19 susceptibility and long-term consequences. [2021]