NCT05836402Completed
Long COVID-19 Syndrome Lifestyle Intervention Study
Low-Carbohydrate Dietary and Lifestyle Interventions for the Management of Long COVID-19 Syndrome: A Prospective and Interventional Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
Rationale: Hyper-inflammatory responses seen in acute COVID-19 are also a feature of long covid, a condition of long-term consequences that are persisting or appearing after initial infection and recovery from acute COVID-19. Long-standing, often disabling symptoms are common in long covid and can be highly varied. Common symptoms include fatigue, brain fog, muscle and chest pain, migraines, shortness of breath, anosmia, muscle weakness, and cognitive dysfunction. 35% of post-COVID patients were found to have decreased kidney function at 6 months post-discharge. In this study, we will evaluate the effect of dietary interventions in long covid patients. The dietary interventions are aimed at lowering blood glucose levels, and raising blood BHB levels. The dietary plan will recommend a low-carbohydrate diet including the avoidance of foods containing sugars and starch, while simultaneously increasing the consumption of healthy fats and sources of protein. The dietary interventions are supported by the consumption of a medical food that delivers exogenous BHB in order to raise blood BHB levels without the necessity of adhering to a strict ketogenic diet which would be difficult to implement and typically requires strict medical supervision. Intervention: Dietary intervention with Ketocitra versus control arm (no intervention) in a 1:1 ratio Objectives: The hypothesis of this study is that low-carbohydrate dietary interventions leading to lowering of blood glucose and raising of blood BHB in addition to standard therapy will lead to faster recovery and amelioration of symptoms in long covid compared to those treated with standard therapy alone. Study population: Subjects with a history of COVID-19 at least 2 months ago and with at least 2 neurological and/or symptoms that are typical for long covid that either started at COVID-19 infection and are ongoing at time of study entry Study methodology: Prospective and interventional randomized controlled pilot study Study arms: Dietary intervention (including medical food) arm versus control arm Study endpoints: The primary endpoint is the feasibility, safety and tolerability of dietary intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 25 Apr 2023
- Start date
- 14 Sept 2023
- Primary completion date
- 4 Aug 2025
- Lead sponsor
- University of Southern California
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05836402
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 14 Sept 2023 to the primary completion date, 4 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on a dialysis treatment
Other illness
- Intolerance or allergy to any of the ingredients in the provided medical food.
Lab values
- 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.
Other
- Subjects who are hospitalized.
- 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.
- Oxygen-dependent with an increase in the last month
- Currently following a low-carbohydrate or ketogenic diet
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keck School of Medicine of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.