Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05836402
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05836402
Study Brief:
Protocol Section:
NCT05836402