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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smartfish AS
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
NF Cachexia
Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).
Intervention: Nutrifriend Cachexia (Dietary Supplement)
Placebo
An isocaloric placebo comparator
Intervention: Isocaloric placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
Time Frame: 12 weeks
Secondary Outcomes
- QoL assessed by Nutrition Appetite Questionnaire (CNAQ)(12 weeks)
- Function assessed by walking distance(12 weeks)
- QoL assessed by COPD Assessment Test (CAT)(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)
- Inflammation(12 weeks)
- QoL assessed by COPD Clinical Questionnaire (CCQ)(12 weeks)
- Compliance assessed by vitamin D levels(12 weeks)
- Metabolic markers(12 weeks)
- Compliance assessed by Drinks consumed(12 weeks)
- Compliance assessed by Omega-3 incorporation(12 weeks)
- QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire(12 weeks)
- QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)(12 weeks)