Last updated: April 26, 2024
Sponsor: University of Southern California
Overall Status: Active - Recruiting
Phase
N/A
Condition
Covid-19
Treatment
Low carbohydrate diet intervention
Clinical Study ID
NCT05836402
HS-22-00640
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years of age or older.
- Positive test result for SARS-CoV-2 (PCR or antigen test) at least 2 months prior tostudy entry.
- At least two neurological and/or physical symptoms that are typical for long covid andthat either started at COVID-19 infection and are ongoing at study entry, or that haveappeared after the acute phase of COVID-19 infection. Typical symptoms includefatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath,loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chestpain, as well as no sign of AKI recovery or establishment of a new diagnosis of CKD.
Exclusion
Exclusion Criteria:
- Subjects who are hospitalized.
- Any significant systemic illness or medical condition or use of medication that couldaffect 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 asaluminum 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 regardingrestrictive behaviors
- History of gastric bypass
- Active diagnosis of ulcerative colitis, Irritable Bowel Syndrome, Crohn's orGallbladder 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 thatseverely impairs bone mineral homeostasis.
- Any other condition, that in the opinion of the enrolling physician, makesthe subject an unsuitable candidate for the study.
- Participants who are pregnant, planning to become pregnant, or nursing within thestudy period.
- Inability or unwillingness to implement dietary changes including the use of themedical 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 dataand data relevant to this study.
- Inability or unwillingness to be reached by phone or video call by a study coordinatoror assistant in order to obtain any missing health data and data relevant to thisstudy.
- 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
Study Design
Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Low carbohydrate diet intervention
Phase:
Study Start date:
September 14, 2023
Estimated Completion Date:
March 31, 2025
Study Description
Connect with a study center
Keck School of Medicine of USC
Los Angeles, California 90033
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.