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

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Dietary supplement: Food supplement; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Food supplement; One tablet a day, during 12 months	Dietary supplement: Food 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_COMPARATOR: Placebo; One tablet a day, during 12 months	Dietary supplement: Placebo; Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	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.	12 months

Collaborators and Investigators

• Sponsor: Arafarma Group, S.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2020
• Primary Completion (ACTUAL): September 15, 2022
• Study Completion (ACTUAL): November 3, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ARA-EXP/ARA-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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