Clincosm LogoSign in Get a demo

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

Sponsor
Smartfish AS (Industry)
Overall Status
Completed
CT.gov ID
NCT02442908
Collaborator
(none)
45
Enrollment
4
Locations
2
Arms
13
Duration (Months)
11.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Nutrifriend Cachexia
  • Dietary Supplement: Isocaloric placebo
 N/A

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

Study Type:
Interventional
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 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Body composition assessed by fat mass and lean body mass (LBM) [12 weeks]

    2. Body composition assessed by weight, BMI and waist & calf circumference [12 weeks]

    3. Function assessed by 6 minute walking test [12 weeks]

    4. Function assessed by grip strength [12 weeks]

    5. Function assessed by walking distance [12 weeks]

    6. Inflammation [12 weeks]

      IL-6, IL-8, TNF-alpha, CRP

    7. Metabolic markers [12 weeks]

      Glucose, insulin, cholesterol

    8. QoL assessed by COPD Assessment Test (CAT) [12 weeks]

    9. QoL assessed by COPD Clinical Questionnaire (CCQ) [12 weeks]

    10. QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C) [12 weeks]

    11. QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire [12 weeks]

    12. QoL assessed by Nutrition Appetite Questionnaire (CNAQ) [12 weeks]

    13. Compliance assessed by Drinks consumed [12 weeks]

    14. Compliance assessed by vitamin D levels [12 weeks]

    15. Compliance assessed by Omega-3 incorporation [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ladulaas kliniska studier Borås Sweden 50630
    2 Pharmasite Helsingborg Sweden 25220
    3 Pharmasite Malmö Sweden 21152
    4 A+ Science City Site Stockholm Sweden 11157

    Sponsors and Collaborators

    • Smartfish AS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Smartfish AS
    ClinicalTrials.gov Identifier:
    NCT02442908
    Other Study ID Numbers:
    • SF-K002
    First Posted:
    May 13, 2015
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Wasting Syndrome
    Cachexia

    Study Results

    No Results Posted as of Dec 24, 2020