Lifestyle intervention for managing long COVID-19 symptoms
Low-Carbohydrate Dietary and Lifestyle Interventions for the Management of Long COVID-19 Syndrome: A Prospective and Interventional Randomized Controlled Pilot Study
This study tests if a low-carbohydrate ketogenic diet can help people with long COVID-19 feel better by reducing their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05836402 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of dietary interventions, specifically a low-carbohydrate ketogenic diet, on patients suffering from long COVID-19 syndrome. The approach aims to lower blood glucose levels and increase levels of beta-hydroxybutyrate (BHB), a ketone body with anti-inflammatory properties. Participants will follow a dietary plan that emphasizes healthy fats and proteins while avoiding sugars and starches. The study focuses on patients with persistent neurological and physical symptoms following COVID-19 infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have tested positive for SARS-CoV-2 and are experiencing ongoing neurological or physical symptoms typical of long COVID.
Not a fit: Patients who are currently hospitalized or have significant systemic illnesses that could interfere with the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly alleviate the debilitating symptoms associated with long COVID-19, improving patients' quality of life.
How similar studies have performed: While the ketogenic diet has been used effectively in other contexts, this specific application for long COVID-19 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 18 years of age or older.
* Positive test result for SARS-CoV-2 (PCR or antigen test) at least 2 months prior to study entry.
* At least two neurological and/or physical symptoms that are typical for long covid and that either started at COVID-19 infection and are ongoing at study entry, or that have appeared after the acute phase of COVID-19 infection. Typical symptoms include fatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath, loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chest pain, as well as no sign of AKI recovery or establishment of a new diagnosis of CKD.
Exclusion Criteria:
* Subjects who are hospitalized.
* Any significant systemic illness or medical condition or use of medication that could affect the safety of the research subject or could affect compliance with the study, as determined by the study personnel and a physician.
* Medications include, but are not limited to:
* KetoCitra
* Urine alkalizing agents such as sodium bicarbonate or potassium citrate
* Citrate treatments
* Calcium supplements
* Use of antacids or phosphate binders containing aluminum.
* SGLT2 inhibitors (e.g. canagliflozin, dapagliflozin)
* Active use of aluminum-containing supplements or medications such as aluminum antacids (e.g. Maalox) or aluminum-based phosphate binders
* Immunosuppressive treatment
* Health conditions include but are not limited to:
* Chronic hyperkalemia
* HIV infection
* Chronic drug or alcohol abuse
* Chronic malabsorption syndrome
* Malignancy (non-melanoma skin cancer exempted)
* Autoimmune disease
* Current or past history of disordered eating or feeding behaviors regarding restrictive behaviors
* History of gastric bypass
* Active diagnosis of ulcerative colitis, Irritable Bowel Syndrome, Crohn's or Gallbladder Disease
* Chronic history or active urinary tract infection (≥ 3/12 months)
* Diabetes mellitus Type 1 or insulin-dependent Type 2.
* Heart failure
* Liver cirrhosis
* Chronic kidney disease stage III or greater, or other renal condition that severely impairs bone mineral homeostasis.
* Any other condition, that in the opinion of the enrolling physician, makes the subject an unsuitable candidate for the study.
* Participants who are pregnant, planning to become pregnant, or nursing within the study period.
* Inability or unwillingness to implement dietary changes including the use of the medical food.
* Inability or unwillingness to submit to blood testing.
* Inability or unwillingness to self-monitor health data.
* Inability or unwillingness to maintain a regular online journal to enter health data and data relevant to this study.
* Inability or unwillingness to be reached by phone or video call by a study coordinator or assistant in order to obtain any missing health data and data relevant to this study.
* Intolerance to low-carbohydrate dietary changes.
* Intolerance or allergy to any of the ingredients in the provided medical food.
* Oxygen-dependent with an increase in the last month
* Currently following a low-carbohydrate or ketogenic diet
* Currently on a dialysis treatment
Where this trial is running
Los Angeles, California
- Keck School of Medicine of USC — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Melissa Ramos
- Email: melissa.ramos@med.usc.edu
- Phone: 3234427983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.