Diet and Exercise for Post-COVID Syndrome

(MARVEL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Monica C Serra, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must not be taking: Insulin, Anti-coagulants

Disqualifiers: Neurologic, Autoimmune, Uncontrolled diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The research in this VA Merit will examine the effects of obesity and Post-COVID Conditions (PCC) on physical functioning, health-related quality of life, and adipose tissue inflammatory and cellular senescence profiles in older Veterans. Further, it will evaluate whether a weight loss intervention, including dietary modification and exercise, in obese Veterans with and without PCC will reduce systemic and adipose tissue inflammation and senescence and promote PCC recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using anti-coagulant medications. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment for post-COVID syndrome?

Research suggests that maintaining a healthy diet and regular exercise can help improve recovery from post-COVID syndrome. Studies highlight the importance of nutritional education and support, as well as staying physically active, to optimize recovery and manage symptoms effectively. ^{1 2 3 4 5}

Is the Diet and Exercise Program safe for humans?

The research does not provide specific safety data for the Diet and Exercise Program, but generally, diet and exercise interventions are considered safe for most people. It's always best to consult with a healthcare provider before starting any new program, especially if you have existing health conditions. ^{2 3 6 7 8}

How does the Diet and Exercise for Post-COVID Syndrome treatment differ from other treatments for this condition?

This treatment is unique because it combines dietary modifications and a structured exercise program specifically designed to address post-COVID syndrome, focusing on weight loss and improving physical health, whereas no standard treatment currently exists for this condition. ^{2 3 5 9 10}

Research Team

Monica C Serra, PhD

Principal Investigator

South Texas Health Care System, San Antonio, TX

Eligibility Criteria

This trial is for older U.S. Veterans who are either overweight or obese, with a BMI of 19-25 or 30-40 kg/m2. It's suitable for those with no Post-COVID symptoms or at least one symptom lasting more than four weeks. Women must be postmenopausal. Participants should not have conditions affecting study assessments, significant weight change recently, use anticoagulants, uncontrolled diabetes, active diseases including inflammatory and autoimmune, nor substance abuse issues.

Inclusion Criteria

I am a woman who has gone through menopause.

I either have no Post-COVID symptoms or have had symptoms for more than 4 weeks.

U.S. Veteran

Exclusion Criteria

I am taking blood thinner medications.

I do not have active inflammation, COVID-19, autoimmune, liver, kidney, stomach issues, cancer, or severe mental health problems.

My diabetes is not under control, with HbA1c over 10% or I'm using insulin.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will undergo a weight loss intervention including dietary modification and exercise, or a weight stability program with health education and stretching/balance classes

12 weeks

1x/week center-based nutrition or health education class, 2x/week center-based exercise or stretching/balance classes, 1x/week self-conducted session

Follow-up

Participants are monitored for changes in cardiorespiratory fitness and adipose tissue cellular senescence

4 weeks

Treatment Details

Interventions

• 12-weeks of Weight Loss (Behavioural Intervention)
• 12-weeks of Weight Stability (Behavioural Intervention)

Trial Overview The study tests if a weight loss program involving diet changes and exercise can reduce inflammation in fat tissue and improve recovery from Post-COVID Conditions (PCC) in obese Veterans. The intervention lasts for 12 weeks focused on losing weight followed by another 12 weeks aimed at maintaining the new weight.

Participant Groups

Group I: Weight Loss Experimental Treatment 1 Intervention

Participants will be asked to participate in a 1x/week center-based nutrition diet class, 2x/week center-based exercise classes, and 1x/week exercise session conducted on their own for 12 weeks.

Group II: Weight Stability Active Control 1 Intervention

Participants will be asked to participate in a 1x/week center-based health education class, 2x/week center-based stretching/balance classes, and 1x/week stretching/balance session conducted on their own for 12 weeks.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Baltimore VA Medical Center

Collaborator

Trials

33

Recruited

3,000+

South Texas Veterans Health Care System

Collaborator

Trials

19

Recruited

6,100+

Baltimore Veterans Affairs Medical Center

Collaborator

Trials

5

Recruited

470+

Findings from Research

Patients recovering from COVID-19, especially those with obesity, may benefit from a combined approach of a ketogenic diet followed by a Mediterranean diet, along with a physical activity program to alleviate post-COVID syndrome symptoms.

There is currently no established nutritional guideline for managing post-COVID syndrome, highlighting the need for further research in this area to optimize recovery strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the Ketogenic Diet to the Mediterranean Diet: The Potential Dietary Therapy in Patients with Obesity after CoVID-19 Infection (Post CoVID Syndrome). Barrea, L., Vetrani, C., Caprio, M., et al.[2022]

In a study of 185 COVID-19 survivors, those with overweight or obesity experienced significant weight loss during hospitalization, but showed a notable increase in weight and waist circumference three months after discharge, indicating rapid fluctuations in body composition.

Factors such as male sex, increased hunger levels, and initial weight loss were identified as predictors for weight gain in these patients, suggesting that monitoring these aspects could be important for managing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight trajectories and abdominal adiposity in COVID-19 survivors with overweight/obesity. Di Filippo, L., De Lorenzo, R., Cinel, E., et al.[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]

The SWiM-C intervention, designed to help adults manage weight during the COVID-19 pandemic, did not show a significant effect on weight loss compared to standard advice, with a baseline-adjusted weight change difference of -0.81 kg.

Participants in the SWiM-C group reported improvements in eating behaviors, such as reduced uncontrolled and emotional eating, as well as increased physical activity, indicating positive changes in lifestyle factors associated with weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention. Mueller, J., Richards, R., Jones, RA., et al.[2023]

A telemedicine-delivered very-low-carbohydrate intervention targeting nutritional ketosis resulted in significant weight loss for both pandemic and pre-pandemic cohorts, with an average weight loss of 7.5% and 7.9% respectively over one year.

The weight loss trajectory was similar for both groups, indicating that the intervention was effective regardless of the pandemic's impact on lifestyle and stress, demonstrating its robustness as a weight management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the COVID-19 Pandemic on the Effectiveness of a Metabolic Health Telemedicine Intervention for Weight Loss: A Propensity Score Matching Analysis. Athinarayanan, SJ., Adams, RN., VanTieghem, M., et al.[2022]

Participants in the COVID cohort (n=81) experienced greater weight loss compared to pre-COVID cohorts, losing an average of 8.5 kg by week 39, despite the challenges posed by the pandemic.

The COVID cohort reported better dietary adherence during the intervention, indicating that continued behavioral support can lead to successful weight loss even in difficult circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the COVID-19 pandemic on weight loss in participants in a behavioral weight-loss intervention. Zaman, A., Sloggett, KJ., Caldwell, AE., et al.[2023]

A study involving 57 patients with persistent fatigue post-COVID showed that a 4-week supervised exercise program significantly improved their maximal exercise capacity (VO2peak) compared to usual care, with no adverse events reported.

While both exercise and usual care groups experienced improvements in fatigue and quality of life over time, the exercise group engaged in significantly more physical activity during the follow-up period, suggesting that exercise is a safe option for enhancing recovery in post-COVID patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise as a treatment for persisting symptoms post-COVID infection: review of ongoing studies and prospective randomized controlled training study. Kogel, A., Machatschek, M., Scharschmidt, R., et al.[2023]

References

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

Nutritional Inadequacies Among Post-bariatric Patients During COVID-19 Quarantine in Sao Paulo, Brazil. [2022]

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

From the Ketogenic Diet to the Mediterranean Diet: The Potential Dietary Therapy in Patients with Obesity after CoVID-19 Infection (Post CoVID Syndrome). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Weight trajectories and abdominal adiposity in COVID-19 survivors with overweight/obesity. [2023]

4. 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]

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

Nutritional and lifestyle changes required for minimizing the recovery period in home quarantined COVID-19 patients of Punjab, Pakistan. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of the COVID-19 Pandemic on the Effectiveness of a Metabolic Health Telemedicine Intervention for Weight Loss: A Propensity Score Matching Analysis. [2022]

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

The effects of the COVID-19 pandemic on weight loss in participants in a behavioral weight-loss intervention. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Physical exercise as a treatment for persisting symptoms post-COVID infection: review of ongoing studies and prospective randomized controlled training study. [2023]