Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NF Cachexia | Experimental | Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula). |
|
| Placebo | Placebo Comparator | An isocaloric placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrifriend Cachexia | Dietary Supplement | 2 daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ladulaas kliniska studier | Borås | 50630 | Sweden | |||
| Pharmasite |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28891198 | Background | Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Ohlander M, Schols A. Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):28-40. doi: 10.1002/jcsm.12228. Epub 2017 Sep 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Isocaloric placebo | Dietary Supplement | 2 daily for 12 weeks |
|
|
| 12 weeks |
| Function assessed by grip strength | 12 weeks |
| Function assessed by walking distance | 12 weeks |
| Inflammation | IL-6, IL-8, TNF-alpha, CRP | 12 weeks |
| Metabolic markers | Glucose, insulin, cholesterol | 12 weeks |
| 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 |
| 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 |
| Helsingborg |
| 25220 |
| Sweden |
| Pharmasite | Malmö | 21152 | Sweden |
| A+ Science City Site | Stockholm | 11157 | Sweden |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |