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NCT Number: NCT06967428

Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort

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.

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Key information

Conditions

Vaccine Adverse Reaction Post Acute Covid-19 Vaccination Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined metabolic modulator

Combination Product

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.

Rice Protein Powder with Vitamin C

Dietary Supplement

Rice Protein Powder (39g) with Vitamin C (1g) daily

Primary outcomes

  1. PAC-19QoL Questionnaire

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).

  2. Six-minute walk test

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    A treadmill-administered version of the six minute walk test (6MWT) where patients walk for as long a distance as they can, without jogging or running, in 6 minutes.

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Hemoglobin A1c (HbA1c) reflects longer term blood sugar levels. Given that metabolism is altered in PACS patients, it may be valuable to assess their metabolic health. Elevated HbA1c was associated with an increased mortality during the acute phase of the Covid-19.

  2. Sedentary blood lactate

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Blood lactate when the patient is at rest is taken using the Arkray Lactate Pro 2 Sports Blood Lactate Meter, which uses disposable test strips.

  3. Post-exertion blood lactate

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Blood lactate taken after the six-minute walk test.

  4. C-Reactive Protein

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    C-reactive protein (CRP) , a marker of inflammation, has been found to be significantly different between long covid groups vs healthy individuals, as well as between long covid and recovered individuals.

    CRP is quantitatively measured at a laboratory attached to the study clinic using the Roche Cobas b 101 Blood Analyser using Roche cobas b 101 CRP Test Discs, supplied in packs of 10. Each test required a 12 μL sample of capillary whole blood, obtained via finger prick.

    Upon completion of the assay, CRP concentrations are recorded in mg/L with that patient's identification number. The analytical range is 3.0-400 mg/L; if a test returns an error, the value will be reported as missing.

  5. Spike protein levels

    Time frame: From an initial test at enrollment to another at the end of treatment at 3 months"

    Spike protein tests will be performed using the MSD S-PLEX SARS-CoV-2 Spike Kit using a SECTOR Imager 2400 plate reader.

  6. Resting Heart Rate Variability

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Heart Rate Variability is taken at rest using a Garmin vívosmart® 5.

  7. Heart rate variability during 6MWT

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    HRV is taken using a Garmin vívosmart® 5 at the halfway point of the 6 minute walk test.

  8. Resting Heart Rate

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Resting Heart Rate is taken using a Garmin vívosmart® 5.

  9. Heart Rate during 6MWT

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    Average heart rate is taken during the last three minutes of the 6MWT

  10. Post-exercise Borg category-ratio 10 scale

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

    This test is used to assess the level of perceived exertion after the 6MWT by asking participants to rate their exertion on a scale of 1 to 10. This is useful as a measure of exercise intolerance.

  11. Total Cholesterol

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

  12. HDL-Cholesterol

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

  13. LDL-Cholesterol

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

  14. Triglycerides

    Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Halma

CONTACT

[email protected]

+504 8948 1885

Sponsors and collaborators

Lead sponsor

Independent Medical Alliance

Other

Collaborators

  • Open Source Medicine Foundation OU

Registry information

Official study title

Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study

Acronym: ViTAL-SCAN19

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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