Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A 12-Week, Randomised, Placebo Controlled, Multi-Centre, Parallel Group Study Assessing the Safety and Tolerability of Nutrifriend Cachexia (Non-Complete Dietary Formula) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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COPD, Cachexia

Intervention / Treatment
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* Dietary Supplement: Nutrifriend Cachexia
* Dietary Supplement: Isocaloric placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NF Cachexia<br>Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula). | Dietary Supplement: Nutrifriend Cachexia<br>* 2 daily for 12 weeks<br>* Other names: NFCax;|
| Placebo Comparator: Placebo<br>An isocaloric placebo comparator | Dietary Supplement: Isocaloric placebo<br>* 2 daily for 12 weeks<br>* Other names: Placobo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |