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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02442908
Other study ID # SF-K002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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