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

NCT04815499 | Completed

• 1 other identifier: ARA-EXP/ARA-2019-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Food supplement

EXPERIMENTAL

One tablet a day, during 12 months

Dietary Supplement: Food supplement

Placebo

PLACEBO COMPARATOR

One tablet a day, during 12 months

Dietary Supplement: Placebo

Interventions

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.

Food supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arafarma Group, S.A.: lead

Study Sites (1)

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: March 25, 2021
• Study Start: January 14, 2020
• Primary Completion: September 15, 2022
• Study Completion: November 3, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

ES (1)