Skip to main content
OpenTrials
Completed

NCT Number: NCT04815499

Effects of a Food Supplement on Quality of Life in Patients With Chronic Obstructive Pulmonary Disease.

It has been demonstrated that consequences of malnutrition affect a situation of risk and have negative effects on the evolution of chronic obstructive pulmonary disease (COPD), accompanied by higher morbidity and mortality. The impact of malnutrition on the respiratory system affects the respiratory muscles, the lung parenchyma, and the immune system. In summary, the risk of complications can lead to a worsening of the quality of life of the COPD patient. Also, dyspnea as the main symptom of COPD is the one that produces the greatest loss of quality of life, especially in older patients. The components of our authorized food supplement improve the quality of life of the patient. These components maintain the strength and energy of the patient, help the body to recover and regain its optimal state, help improve the immune system, help reduce the side effects of therapies associated with the control or cure of cancer and help correct nutritional deficiencies. This is the reason why this experimental study aims to improve the quality of life in patients with COPD with a CAT score>15.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

About this study

This study is developed in two phases: pilot phase and experimental phase. The pilot phase is preliminary and progressive in order to demonstrate a sufficient effect of improving the quality of life of patients and to be able to continue in an experimental phase with more investigational sites and more patients, and to evaluate other secondary objectives.

Once the pilot phase is finished, an intermediate analysis of the results will be carried out to evaluate the magnitude of the variation in quality of life at 3, 6, 9 and 12 months. If the expected success expectations are achieved and it is approved by the Ethics Committee, the study will continue to the experimental phase.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults: men and women ≥ 18 years.
  • Patients with a medical diagnosis of COPD based on a recent spirometry.
  • Patients with a CAT score> 15, affecting COPD symptoms in a moderate-high way in the daily life of these patients.
  • Minimum clinical stability period of 4 weeks before the start of the study.
  • Patients who are trained to give informed consent.
  • Patients must agree to perform study visits and procedures with precise instructions.

Exclusion criteria

  • BMI ≥ 40.
  • Comorbidities, which due to their severity or progression, may interfere with the results, such as cancer, hematological disorders, severe heart or liver failure, kidney failure on dialysis, tuberculosis (TB) or AIDS, or other pulmonary pathologies such as pulmonary thromboembolism ( PE), pulmonary fibrosis, or relevant bronchiectasis.
  • In Pulmonary Rehabilitation treatment or in treatment for smoking.
  • Pregnancy or breastfeeding.
  • Impossibility of the patient, due to a medical condition, to follow the study.

Treatment and study plan

Food supplement

Dietary Supplement

ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient.

Placebo

Dietary Supplement

Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.

Primary outcomes

  1. Change in quality of life

    Time frame: 12 months

    To assess the magnitude of the change from baseline quality of life at 3 months, 6 months, 9 months and 12 months using the COPD Assessment Test (CAT) scale in COPD patients with a CAT score> 15 who receive ARACOMPLEX® supplementation compared to those patients receiving placebo.

Sponsors and collaborators

Lead sponsor

Arafarma Group, S.A.

Industry

Registry information

Official study title

Study of the Impact on Quality of Life With ARACOMPLEX® Food Supplement Versus Placebo in Chronic Obstructive Pulmonary Disease Patients With a CAT Score> 15.

Acronym: EPOCAT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2021
Registry last updated
Nov 15, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.