COPD, Cachexia
Conditions
Brief summary
SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.
Detailed description
This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with COPD. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, lung function, compliance, appetite and Quality of Life.
Interventions
DIETARY_SUPPLEMENTNutrifriend Cachexia
2 daily for 12 weeks
DIETARY_SUPPLEMENTIsocaloric placebo
2 daily for 12 weeks
Sponsors
Smartfish AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>50 years * Moderate to severe COPD patients with forced expiratory volume (FEV1) of 30-60% * Involuntary weight loss \<10% * 18 kg/m2 ≤ BMI ≤ 32 kg/m2
Exclusion criteria
* Exacerbation of COPD within 3 months prior to screening * Treatment with oral corticosteroids (\>5 mg/day) within 3 months prior to screening * Treatment with anabolic steroids within 3 months prior to screening * Current oxygen treatment or home ventilation therapy * Change in smoking habits during the previous 6 months * Major changes in COPD maintenance treatment within 3 months prior to screening * Other cachectic disorders such as cancer, renal or hepatic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL assessed by COPD Assessment Test (CAT) | 12 weeks | — |
| QoL assessed by COPD Clinical Questionnaire (CCQ) | 12 weeks | — |
| QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C) | 12 weeks | — |
| Body composition assessed by fat mass and lean body mass (LBM) | 12 weeks | — |
| Body composition assessed by weight, BMI and waist & calf circumference | 12 weeks | — |
| Function assessed by 6 minute walking test | 12 weeks | — |
| Function assessed by grip strength | 12 weeks | — |
| Metabolic markers | 12 weeks | Glucose, insulin, cholesterol |
| Inflammation | 12 weeks | IL-6, IL-8, TNF-alpha, CRP |
| QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire | 12 weeks | — |
| QoL assessed by Nutrition Appetite Questionnaire (CNAQ) | 12 weeks | — |
| Compliance assessed by Drinks consumed | 12 weeks | — |
| Compliance assessed by vitamin D levels | 12 weeks | — |
| Compliance assessed by Omega-3 incorporation | 12 weeks | — |
| Function assessed by walking distance | 12 weeks | — |
Countries
Sweden
Outcome results
None listed