Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
NCT ID: NCT02442908
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2015-05-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NF Cachexia
Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).
Nutrifriend Cachexia
2 daily for 12 weeks
Placebo
An isocaloric placebo comparator
Isocaloric placebo
2 daily for 12 weeks
Interventions
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Nutrifriend Cachexia
2 daily for 12 weeks
Isocaloric placebo
2 daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Smartfish AS
INDUSTRY
Responsible Party
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Locations
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Ladulaas kliniska studier
Borås, , Sweden
Pharmasite
Helsingborg, , Sweden
Pharmasite
Malmo, , Sweden
A+ Science City Site
Stockholm, , Sweden
Countries
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References
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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.
Related Links
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Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
Other Identifiers
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SF-K002
Identifier Type: -
Identifier Source: org_study_id