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Purpose

The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing. The main questions it aims to answer are: Does the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients? Does the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)? Researchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles. Participants will: Take the assigned supplement daily for 3 months (ViTAL SCAN or placebo) Attend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring Complete quality of life and health behavior questionnaires Undergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein) Record supplement intake This study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.

Conditions

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Persistent fatigue lasting more than 6 months - Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination) - Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.

Exclusion Criteria

  • Pregnant - History of Schizophrenia - Currently using antidepressant medication

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ViTAL SCAN 		This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to modulate energy metabolism.
  • Combination Product: Combined metabolic modulator
    This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to support energy metabolism.
Active Comparator
Rice Protein Powder and Vitamin C 		A mass-matched supplement of rice protein powder with vitamin C.
  • Dietary Supplement: Rice Protein Powder with Vitamin C
    Rice Protein Powder (39g) with Vitamin C (1g) daily

Recruiting Locations

More Details

NCT ID
NCT06967428
Status
Not yet recruiting
Sponsor
Independent Medical Alliance

Study Contact

Matthew Halma
+504 8948 1885
mhalma@imahealth.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.