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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02442908
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Smartfish AS

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COPD Cachexia Dietary Supplement: Nutrifriend Cachexia Dietary Supplement: Isocaloric placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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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 Name: NFCax
Placebo Comparator: Placebo
An isocaloric placebo comparator
 Dietary Supplement: Isocaloric placebo
2 daily for 12 weeks
Other Name: Placobo


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Body composition assessed by fat mass and lean body mass (LBM) [ Time Frame: 12 weeks ]
  2. Body composition assessed by weight, BMI and waist & calf circumference [ Time Frame: 12 weeks ]
  3. Function assessed by 6 minute walking test [ Time Frame: 12 weeks ]
  4. Function assessed by grip strength [ Time Frame: 12 weeks ]
  5. Function assessed by walking distance [ Time Frame: 12 weeks ]
  6. Inflammation [ Time Frame: 12 weeks ]
    IL-6, IL-8, TNF-alpha, CRP

  7. Metabolic markers [ Time Frame: 12 weeks ]
    Glucose, insulin, cholesterol

  8. QoL assessed by COPD Assessment Test (CAT) [ Time Frame: 12 weeks ]
  9. QoL assessed by COPD Clinical Questionnaire (CCQ) [ Time Frame: 12 weeks ]
  10. QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C) [ Time Frame: 12 weeks ]
  11. QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire [ Time Frame: 12 weeks ]
  12. QoL assessed by Nutrition Appetite Questionnaire (CNAQ) [ Time Frame: 12 weeks ]
  13. Compliance assessed by Drinks consumed [ Time Frame: 12 weeks ]
  14. Compliance assessed by vitamin D levels [ Time Frame: 12 weeks ]
  15. Compliance assessed by Omega-3 incorporation [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442908


Locations
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Sweden
Ladulaas kliniska studier
Borås, Sweden, 50630
Pharmasite
Helsingborg, Sweden, 25220
Pharmasite
Malmö, Sweden, 21152
A+ Science City Site
Stockholm, Sweden, 11157
Sponsors and Collaborators
Smartfish AS
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Smartfish AS
ClinicalTrials.gov Identifier: NCT02442908    
Other Study ID Numbers: SF-K002
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Emaciation
Weight Loss
Body Weight Changes
 Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders