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NCT05836402 · ClinicalTrials.gov registry record · NA
Long COVID-19 Syndrome Lifestyle Intervention Study
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT05836402 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 14 participants.
The verdict
NCT05836402, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study 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 a
Interventions
- DIETARY_SUPPLEMENT Low carbohydrate diet intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-09-14 |
| Est. Completion | 2025-08-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05836402
The ClinicalTrials.gov registry entry for NCT05836402 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Low carbohydrate diet intervention is the first listed.
NCT05836402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05836402 about?
NCT05836402 is a clinical study titled "Long COVID-19 Syndrome Lifestyle Intervention Study". 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 b...
What is the current status of trial NCT05836402?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2023-09-14. Estimated completion is 2025-08-04.
What interventions are being tested in trial NCT05836402?
The interventions under investigation include: Low carbohydrate diet intervention (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05836402?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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