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

COPD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442908
• Other study ID #: SF-K002
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2020
• Source: Smartfish AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• COPD

Intervention

Dietary Supplement:
• Nutrifriend Cachexia
2 daily for 12 weeks
• Isocaloric placebo
2 daily for 12 weeks

Locations

Country	Name	City	State
Sweden	Ladulaas kliniska studier	Borås
Sweden	Pharmasite	Helsingborg
Sweden	Pharmasite	Malmö
Sweden	A+ Science City Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Smartfish AS

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Öhlander 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD		12 weeks
Secondary	Body composition assessed by fat mass and lean body mass (LBM)		12 weeks
Secondary	Body composition assessed by weight, BMI and waist & calf circumference		12 weeks
Secondary	Function assessed by 6 minute walking test		12 weeks
Secondary	Function assessed by grip strength		12 weeks
Secondary	Function assessed by walking distance		12 weeks
Secondary	Inflammation	IL-6, IL-8, TNF-alpha, CRP	12 weeks
Secondary	Metabolic markers	Glucose, insulin, cholesterol	12 weeks
Secondary	QoL assessed by COPD Assessment Test (CAT)		12 weeks
Secondary	QoL assessed by COPD Clinical Questionnaire (CCQ)		12 weeks
Secondary	QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)		12 weeks
Secondary	QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire		12 weeks
Secondary	QoL assessed by Nutrition Appetite Questionnaire (CNAQ)		12 weeks
Secondary	Compliance assessed by Drinks consumed		12 weeks
Secondary	Compliance assessed by vitamin D levels		12 weeks
Secondary	Compliance assessed by Omega-3 incorporation		12 weeks

External Links

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