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

Smartfish AS45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COPD Cachexia

Interventions

Nutrifriend CachexiaDIETARY_SUPPLEMENT

2 daily for 12 weeks

Isocaloric placeboDIETARY_SUPPLEMENT

2 daily for 12 weeks

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (4)

Ladulaas kliniska studier

Borås, Sweden

Pharmasite

Helsingborg, Sweden

Pharmasite

Malmö, Sweden

A+ Science City Site

Stockholm, Sweden

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

Body composition assessed by fat mass and lean body mass (LBM)

Time frame: 12 weeks

Body composition assessed by weight, BMI and waist & calf circumference

Time frame: 12 weeks

Function assessed by 6 minute walking test

Time frame: 12 weeks

Function assessed by grip strength

Time frame: 12 weeks

Function assessed by walking distance

Time frame: 12 weeks

Inflammation

IL-6, IL-8, TNF-alpha, CRP

Time frame: 12 weeks

Metabolic markers

Glucose, insulin, cholesterol

Time frame: 12 weeks

QoL assessed by COPD Assessment Test (CAT)

Time frame: 12 weeks

QoL assessed by COPD Clinical Questionnaire (CCQ)

Time frame: 12 weeks

QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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