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

• ClinicalTrials.gov Identifier: NCT02442908
• Recruitment Status: Completed
• First Posted: May 13, 2015
• Last Update Posted: December 24, 2020
• Sponsor: Smartfish AS
• Information provided by (Responsible Party): Smartfish AS

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
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

• 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

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

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

• 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

Locations

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

Additional Information:

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

Publications:

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.

• Responsible Party: Smartfish AS
• ClinicalTrials.gov Identifier: NCT02442908
• Other Study ID Numbers: SF-K002
• First Posted: May 13, 2015
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

Additional relevant MeSH terms:

Wasting Syndrome; Cachexia; Emaciation; Weight Loss; Body Weight Changes; Body Weight; Metabolic Diseases; Nutrition Disorders