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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02442908
• Date of registration: 07/05/2015
• Prospective Registration: No
• Primary sponsor: Smartfish AS
• Public title: Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
• Scientific 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)
• Date of first enrolment: May 2015
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02442908
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cachexia

COPD

Intervention(s)

Dietary Supplement: Isocaloric placebo

Dietary Supplement: Nutrifriend Cachexia

Primary Outcome(s)

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(s)

Function assessed by 6 minute walking test [Time Frame: 12 weeks]

QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire [Time Frame: 12 weeks]

Body composition assessed by weight, BMI and waist & calf circumference [Time Frame: 12 weeks]

Function assessed by walking distance [Time Frame: 12 weeks]

Metabolic markers [Time Frame: 12 weeks]

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

Body composition assessed by fat mass and lean body mass (LBM) [Time Frame: 12 weeks]

Compliance assessed by Omega-3 incorporation [Time Frame: 12 weeks]

Compliance assessed by vitamin D levels [Time Frame: 12 weeks]

Inflammation [Time Frame: 12 weeks]

Compliance assessed by Drinks consumed [Time Frame: 12 weeks]

QoL assessed by COPD Assessment Test (CAT) [Time Frame: 12 weeks]

QoL assessed by COPD Clinical Questionnaire (CCQ) [Time Frame: 12 weeks]

Function assessed by grip strength [Time Frame: 12 weeks]

QoL assessed by Nutrition Appetite Questionnaire (CNAQ) [Time Frame: 12 weeks]

Secondary ID(s)

SF-K002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors