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)

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.

Study Overview

• Status: Completed
• Conditions: Cachexia; COPD
• Intervention / Treatment: Dietary supplement: Nutrifriend Cachexia; Dietary supplement: Isocaloric placebo

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Borås, Sweden, 50630
    • Ladulaas Kliniska Studier
  • Helsingborg, Sweden, 25220
    • PharmaSite
  • Malmö, Sweden, 21152
    • PharmaSite
  • Stockholm, Sweden, 11157
    • A+ Science City site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Smartfish AS

Publications and helpful links

General Publications

• Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Ohlander M, Schols A. Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):28-40. doi: 10.1002/jcsm.12228. Epub 2017 Sep 10.

Helpful Links

• Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: SF-K002