Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition

Summary

SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Once the acute phase of the disease has passed, about 40% of the people who discharged continue to have symptoms, and of these, between 50 and 70% present them up to three months later. These persistent symptoms include physical aspects such as fatigue and dyspnea, but also cardiac such as palpitations, cognitive such as mental confusion, and psycho-emotional such as depression, anxiety, and stress. SARS-CoV-2 infection is associated with a hyperinflammatory state, including excessive inflammatory cell infiltration, inflammasomes activation. In this context, omega-3 metabolites (Special Pro-resolving Mediators-SPMs) restore the balance in nutritional and molecular levels of eicosanoids. A more direct and targeted way to increase SPMs levels is Omega3 Essential Nutrition with natural SPMs taken by mouth. Today, there are dietary supplements containing SPMs (LIPINOVA®), made from fish oil through a fractionation process. LIPINOVA® is a nutritional supplement patented by Solutex GC S.L., obtained through several fractionation stages (extraction, purification, separation, concentration) from rich-in-omega-3 fish oil (without additives). Each capsule contains 498 mg of fish oil and 2 mg of tocopherols. This represents a variable quantity from 50 to 150 mg of EPA (20%), a variable quantity from 100 to 225 mg of DHA (30%), as well as the following quantities of EPA and DHA active metabolites, obtained from a pool of natural lipid mediators contained in omega-3 oil: 40-200 mcg of 17-HDHA, 25-200 mcg of 18-HEPE and 20-100 mcg of 14-HDHA.

In addition to this, the appearance of this new health condition, post-COVID condition, has once again led physiotherapists to update themselves in search of the best evidence to guide the examination and necessary rehabilitation interventions in this type of patient. Studies have shown how physiotherapy sessions that include a multimodal program could be the most indicated for this type of patients. Patients with this condition present an increase in fatigue, dyspnea and a decrease in their functional capacity and, therefore, a decrease in their quality of life, due to various pathogenic mechanisms that include chronic hyperinflammation.

These patients could obtain greater health improvements in terms of their quality of life if a therapeutical exercise and education program based on tele-rehabilitation is implemented together with a natural nutritional supplement that generates a systemic anti-inflammatory effect through SPMs (omega- 3).

Conditions

• Post-COVID Condition

Interventions

DIETARY_SUPPLEMENT

Active

Active nutritional supplement plus telerehabilitation

OTHER

Placebo

Placebo nutritional supplement plus telerehabilitation

Sponsors & Collaborators

• Solutex GC S.L.

  collaborator INDUSTRY

• Instituto de Investigación Sanitaria Aragón

  lead OTHER

Principal Investigators

• Jorge Alamillo Salas, Dr · SALUD

• Sandra Calvo Carrión., Dr · Universidad de Zaragoza

• Beatriz Carpallo Porcar, MSc · Universidad San Jorge

• Carolina Jiménez Sánchez, Dr · Universidad San Jorge

• Ana Isabel Aller Blanco, Dr · SALUD

• Elena Kolesnyk Sumskaya, Dr · SALUD

• Esther del Corral Beamonte, Dr · SALUD

• Pablo Herrero Gallego, Dr · Universidad de Zaragoza

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-26

Primary Completion

2025-01-15

Completion

2025-04-30

Countries

• Spain

Study Locations