The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.

NCT05150782 | Unknown

• 1 other identifier: MyCellVSLongCOVID
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Food supplements like curcumin and boswellia serrata have been used traditionally for anti-inflammatory purposes. A well-known problem of these substances in their natural form is the low bioavailability. Micellization of these substances has been shown to increase the bioavailability significantly and thereby the clinical efficacy. The clinical value of these micellized substances has been presented in numerous clinical studies and in particular in patients with acute COVID-19. This study aims to examine the effect of a mixture of micellized curcumin, boswellia serrata and ascorbic acid on patients with long COVID.

Conditions

Post-acute COVID-19 Syndrome

Keywords

micelles; dietary supplements

Outcome Measures

Primary Outcomes (1)

• Change in health-related quality of life

  Health-related quality of life is measured with the 'Short-Form 12' (SF-12) from 0 to 100, where higher scores on the SF-12 represent better health-related quality of life.

  Week 1, 2, 3, 4, 5, 6, 10 and 14.

Secondary Outcomes (4)

• Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).

  Week 1, 2, 3, 4, 5, 6, 10 and 14.

• Change in general health status

  Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21

• Change in general health

  Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21

• Change in Post COVID functional status measured with the 'Post COVID Functional Status' (PCFS).

  Week 1, 2, 3, 4, 5, 6, 10 and 14.

Other Outcomes (1)

• Course of general health

  Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21

Study Arms (1)

Curcumin/Boswellia Serrata/Ascorbic acid mixture

EXPERIMENTAL

The daily intake of 2x10 drops of a mixture of micellized curcumin(2%), boswellia serrata (1,5%) and ascorbic acid (6%).

Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture

Interventions

Curcumin/Boswellia Serrata/Ascorbic acid mixture DIETARY_SUPPLEMENT

The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).

Curcumin/Boswellia Serrata/Ascorbic acid mixture

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed SARS-CoV-2 infection at least 28 days prior to study participation
• Patients who are experiencing symptoms of PACS (with a PCFS of 1 or higher)
• years or older and younger than 85
• Good understanding of written German

You may not qualify if:

• Currently under pharmacological treatment for PACS
• Any planned medical surgery or intervention where medication intake is necessary in the coming 14 weeks
• Allergy to curcumin or Boswellia
• Active malignancy
• Medical history of Human Immunodeficiency Virus (HIV) infection, or any serious immunocompromised state.
• Pregnancy (or planned pregnancy in the coming 14 weeks) ( - Patients who are taking anticoagulants or have diabetes type I or II are only allowed to participate if their general practitioner is informed)

Sponsors & Collaborators

• PhysioMetrics: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Curcumin

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Denis Kangeldi, MSc

  Cognitive Health Platform AG

  STUDY DIRECTOR

Central Study Contacts

Maurice de Graaf, MSc

CONTACT

+41 32 530 52 84; longcovid@physiometrics.ch

Liana S de Graaf

CONTACT

+41 79 936 57 77; info@physiometrics.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm intervention

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 9, 2021
• Study Start: January 17, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available as soon as the results are published. The availability of the data is 5 years.
• Access Criteria: i) Affiliated researcher, 2) researcher must be able to demonstrate that accessing the raw study data is necessary to be able to conduct his/her research project