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

Smartfish

Status

Completed

Conditions

Cachexia

COPD

Treatments

Dietary Supplement: Nutrifriend Cachexia

Dietary Supplement: Isocaloric placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02442908

SF-K002

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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