NCT05836402

Long COVID-19 Syndrome Lifestyle Intervention Study

Completed NA Last updated 7 August 2025

What this trial tests

NA trial testing Low carbohydrate diet intervention in Long COVID-19 Syndrome in 14 participants. Completed in 4 August 2025.

Timeline

14 September 2023

Primary endpoint
4 August 2025

4 August 2025

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	14
Start date	14 September 2023
Primary completion	4 August 2025
Estimated completion	4 August 2025
Sites	1 location across United States

Drugs / interventions tested

• Low carbohydrate diet intervention

Conditions studied

• Long COVID-19 Syndrome — all drugs for Long COVID-19 Syndrome →

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Long COVID-19 Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.