Long COVID-19 Syndrome Lifestyle Intervention Study
Long COVID-19 Syndrome
About this trial
This is an interventional other trial for Long COVID-19 Syndrome focused on measuring Keto, beta-hydroxybutyrate, citrate, ketogenic
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
Sites / Locations
- Keck School of Medicine of USCRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Low Carbohydrate
-Usual diet.
-Low-Carbohydrate Diet Intervention:Patients will receive a study kit. The kit will contain the following: Instruction sheet containing medical food instructions and food journal and a web link to the weekly online journal A 30-day supply of the medical food, KetoCitra, developed by Santa Barbara Nutrients, Inc. KetoCitra® is a ready-to-mix powder to be dissolved in water and taken twice per day with meals. KetoCitra® contains BHB, citrate, and a blend of minerals (potassium, calcium, magnesium) and is flavored with natural lemon flavor and stevia natural sweetener. KetoCitra® is sugar- and sodium-free and is intended to support the metabolic switch aimed for with the low-carbohydrate diet by providing exogenous BHB. (Package insert)