Nutritional Supplementation in Adults With Chronic Respiratory Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

— OFOS  

Official title:

Impact of Nutritional Support With an Complete Formula on Nutritional Status and Respiratory Function in Adult Patients Malnourished or at Risk of Malnutrition and Chronic Respiratory Disease..

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102009
• Other study ID #: OFOS-01-012
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard hospital dietary advise.

Description:

This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to evaluate the effect of a nutritional formula on nutritional status, pulmonary function and quality of life. Adult patients will be randomized to receive the nutritional formula or to follow the standard hospital' dietetic recommendations during 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged between 18 and 80 years.

• Patient from Clínica San Gabriel or Clínica San Pablo Surco, inpatient or outpatient.

• Patients with chronic pulmonary disease (including bronchiectasis, tuberculosis specific sequel, fibrothorax, diffuse interstitial lung disease, COPD).

• Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients = 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last moth; FFMI <15 kg/m2 (women) or <16 kg/m2 (men).

• Patients who signed informed consent.

Exclusion Criteria:

• Clinically unstable patients.

• Patients requiring other nutritional supplements or parenteral nutrition.

• Patients diagnosed with active pulmonary tuberculosis.

• Patients with acute respiratory failure.

• Patients with immunosuppression (including HIV, diabetes or neoplasms).

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Malnutrition
• Other Pulmonary Disease, Chronic Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Dietary Supplement:
• Complete enteral formula
Product: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product). Time of intervention: 3 months.

Other:
• Dietary Advise
Patients will receive the usual dietary advise in these patients according hospital clinical practice .

Locations

Country	Name	City	State
Peru	Clínica San Gabriel	San Miguel	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Peruvian Clinical Research

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nutritional status	Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.	At hospital discharge or at 1th month and at 3 months
Primary	Changes in pulmonary function	Differences in forced expiratory volume measured by spirometry.	At 3rd month
Secondary	Respiratory Infections	Differences measured by number of infections and hospital readmission rate.	At 1st, 2nd, 3rd month
Secondary	Muscular Strength	Differences measured by hand-grip strength.	At 3rd month.
Secondary	Exercise Tolerance	Differences measured by six minutes walk test.	At 3th month
Secondary	Quality of Life of the participants	Differences measured by Saint George respiratory questionnaire.	At hospital discharge or 1st month and 3rd month
Secondary	Tolerability of the product	Measured by gastrointestinal discomfort and product compliance.	At 1st, 2nd and 3rd months