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..
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Changes in nutritional status
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Vitafos
Complete enteral formula
Intervention: Complete enteral formula (Dietary Supplement)
Dietary Advise
Dietary advise according to the hospital routine clinical practice.
Intervention: Dietary Advise (Other)
Outcomes
Primary Outcomes
Changes in nutritional status
Time Frame: At hospital discharge or at 1th month and at 3 months
Differences in weight, body mass index and fat free mass index evaluated by anthropometric measures.
Changes in pulmonary function
Time Frame: At 3rd month
Differences in forced expiratory volume measured by spirometry.
Secondary Outcomes
- Respiratory Infections(At 1st, 2nd, 3rd month)
- Muscular Strength(At 3rd month.)
- Exercise Tolerance(At 3th month)
- Quality of Life of the participants(At hospital discharge or 1st month and 3rd month)
- Tolerability of the product(At 1st, 2nd and 3rd months)