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

The Effect of a Mixture of Micellized Curcumin/Boswellia Serrata/Ascorbic Acid on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-acute COVID-19 Syndrome
• Intervention / Treatment: Dietary supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture

Detailed Description

The participants will be asked to take the micellized supplements daily, at home for 6 weeks. During this 6 weeks several questionnaires will be taken to asses general health-related quality of life. Follow-up measurements will be done at 14 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maurice de Graaf, MSc; Phone Number: +41 32 530 52 84; Email: longcovid@physiometrics.ch
• Study Contact Backup: Name: Liana S de Graaf; Phone Number: +41 79 936 57 77; Email: info@physiometrics.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)
• 18 years or older and younger than 85
• Good understanding of written German

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin/Boswellia Serrata/Ascorbic acid mixture; 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; The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).	Patient specific limitations in daily life are measured with the 'Patient Specific Functional Scale' (PSFS). The scale is a visual analogue scale ranging from 0 to 100, with 0 meaning no limitations in the patient selected functional activity and 100 means it is impossible to perform this activity.	Week 1, 2, 3, 4, 5, 6, 10 and 14.
Change in general health status	Change in general health status is measured with a dichotomous yes or no question.	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	Percentage of change of general health is asked for, where 0 represents no change and 100% means complete change,	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).	Self-Test for ordinal scaling of degree of post-COVID symptoms with 0 representing no symptoms and 4 several functional limitations.	Week 1, 2, 3, 4, 5, 6, 10 and 14.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Course of general health	Graphical depiction of course of self-perceived change 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

Collaborators and Investigators

• Sponsor: PhysioMetrics
• Investigators: Study Director: Denis Kangeldi, MSc, Cognitive Health Platform AG

Study record dates

Study Major Dates

• Study Start (Anticipated): January 17, 2022
• Primary Completion (Anticipated): October 10, 2022
• Study Completion (Anticipated): October 10, 2022

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: dietary supplements; micelles
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid; Curcumin
• Other Study ID Numbers: MyCellVSLongCOVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data are available for researchers upon request.
• IPD Sharing Time Frame: The data will become available as soon as the results are published. The availability of the data is 5 years.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No