Clinical trial NCT06992414: Exploring the Therapeutic Effects of Creatine Supplementation for Long COVID-19
Official title: Exploring Creatine Supplementation for Improved Exercise Capacity and Reduced Fatigue in Long COVID-19: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID Fatigue
Keywords: creatine
post-exertional malaise
exercise
nutraceutical
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to the treatment or control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM

Detailed description: cognitive dysfunction, and post-exertional malaise are common complaints of those living with Post-COVID Condition (PCC), a sequelae of symptoms that persist beyond acute infection. Similar to other types of post-viral fatigue, the diagnosis and treatment of PCC are challenging due to the lack of a valid biomarker for the condition. Though the etiology of PCC is not well understood, recent research has found reduced skeletal muscle creatine concentration in those with PCC, which may contribute to fatigue. The objective of this study is to determine if eight weeks of creatine monohydrate supplementation (8g/day) improves symptoms of fatigue, cognition, exercise capacity, and PEM in individuals living with PCC.

Participants will complete two cardiopulmonary exercise tests 24-hours apart on a cycle ergometer before and after an eight-week intervention period. Venous blood samples will be collected before and after exercise on both days to assess changes in mitochondrial function. During the intervention, participants will be randomly assigned to supplement with 8g/day of either creatine monohydrate or a control (maltodextrin). Cognition will be indirectly assessed via self-report of cognitive symptom frequency and severity at baseline, mid-intervention (i.e., 4 weeks) and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Experiencing symptoms at least 3 months after a COVID-19 diagnosis confirmed by positive polymerase chain reaction (PCR) test
* Experiencing post-exertional malaise, as per the DePaul Symptom Questionnaire

Exclusion Criteria:

* Allergy or intolerance to creatine monohydrate or maltodextrin
* Supplemented with creatine in the past eight weeks
* orthopaedic injury or condition that would prevent exercise testing
* change in medication related to Long COVID symptom management in the past month.

Primary outcomes:
measure: Oxygen consumption at ventilatory threshold
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Heart rate at ventilatory threshold
timeFrame: From enrollment to the end of intervention at 8 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)
measure: Brain fog
timeFrame: From baseline to mid intervention (4 weeks) to post intervention (8 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Keely A Shaw, PhD
role: PRINCIPAL_INVESTIGATOR
References: