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Diet and Exercise for Post-COVID Syndrome (MARVEL Trial)

N/A

Recruiting

Led By Monica C Serra, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal status for women

No Post-COVID symptoms or at least one Post-COVID symptom lasting >4 weeks

Must not have

Active inflammatory, COVID-19, autoimmune, infectious, hepatic (LFTs > 2.5 x WNL), renal (eGFR<45), gastrointestinal, malignant, and psychiatric disease

Uncontrolled diabetes (HbA1c >10% or the current use of insulin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how obesity and COVID-19 affect aging Veterans, and whether diet and exercise can reduce inflammation and help recovery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical risks associated with dietary changes and increased physical activity such as muscle soreness, fatigue, nutritional deficiencies if not monitored properly, and possible exacerbation of underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who has gone through menopause.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 12 weeks of weight loss

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 12 weeks of weight loss

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 12 weeks of weight loss for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiorespiratory Fitness (VO2max)

Secondary study objectives

Change in Cardiorespiratory Fitness (VO2max)

Change in adipose tissue cellular senescence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weight LossExperimental Treatment1 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 StabilityActive Control1 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.

0 / 4Eligibility criteria met