NCT02442908

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Smartfish AS · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Cachexia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrifriend Cachexia	2 daily for 12 weeks
DIETARY_SUPPLEMENT	Isocaloric placebo	2 daily for 12 weeks

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2015-05-13
• Last updated: 2020-12-24

Locations

4 sites across 1 country: Sweden