Long COVID-19 Syndrome Lifestyle Intervention Study

NCT05836402 | Completed

• 1 other identifier: HS-22-00640
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID-19 Syndrome

Keywords

Keto; beta-hydroxybutyrate; citrate; ketogenic

Outcome Measures

Primary Outcomes (8)

• Feasibility of dietary intervention:

  Questionnaire on diet feasibility (Appendix F). Exit Questionnaire. Scale 1-5 (1= worse outcome; 5=better outcome)

  One month

• Safety signals for electrolytes

  calcium, sodium, potassium, carbon dioxide, chloride,

  At start and at day 30

• Safety signals for kidney function

  BUN and creatinine

  At start and at day 30

• Safety signals for liver function

  Alkaline Phosphatase, ALT, AST, bilirubin, \& total protein, glucose

  At start and at day 30

• Cardiovascular risk

  Fasting lipid panel: total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides

  At start and at day 30

• Improved uric acid metabolism

  Serum Uric Acid

  At start and at day 30

• kidney function: proteinuria

  urinalysis and urine protein to creatinine ratio

  At start and at day 30

• Safety and tolerability of dietary intervention:

  Questionnaire on parameters of safety and tolerability (Appendix E) 0-10 (Scale 0= best outcome to 10=worse outcome)

  30 days

Secondary Outcomes (11)

• Improvement of long-COVID syndrome signs Measurement of change in body weight

  At start and at day 30

• Improvement of long-COVID syndrome signs Measurement of aerobic capacity:

  At start and at day 30

• Improvement of long-COVID syndrome signs: Measures of inflammation

  At start and at day 30

• Improvement of long-COVID syndrome signs: stability of kidney function

  At start and at day 30

• Improvement of long-COVID syndrome signs: respiratory health review of systems

  One month

Study Arms (2)

Control

NO INTERVENTION

-Usual diet.

Low Carbohydrate

EXPERIMENTAL

-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)

Dietary Supplement: Low carbohydrate diet intervention

Interventions

Low carbohydrate diet intervention DIETARY_SUPPLEMENT

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)

Also known as: Low carbohydrate diet intervention and Ketocitra

Low Carbohydrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Prospective, Interventional, Randomized, Controlled Pilot Study (Treatement with dietary intervention and medical food VS. usual therapy)

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 1, 2023
• Study Start: September 14, 2023
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)