Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
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ClinicalTrials.gov Identifier: NCT02442908 |
Recruitment Status :
Completed
First Posted : May 13, 2015
Last Update Posted : December 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD Cachexia | Dietary Supplement: Nutrifriend Cachexia Dietary Supplement: Isocaloric placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: NF Cachexia
Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).
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Dietary Supplement: Nutrifriend Cachexia
2 daily for 12 weeks
Other Name: NFCax |
Placebo Comparator: Placebo
An isocaloric placebo comparator
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Dietary Supplement: Isocaloric placebo
2 daily for 12 weeks
Other Name: Placobo |
- Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD [ Time Frame: 12 weeks ]
- Body composition assessed by fat mass and lean body mass (LBM) [ Time Frame: 12 weeks ]
- Body composition assessed by weight, BMI and waist & calf circumference [ Time Frame: 12 weeks ]
- Function assessed by 6 minute walking test [ Time Frame: 12 weeks ]
- Function assessed by grip strength [ Time Frame: 12 weeks ]
- Function assessed by walking distance [ Time Frame: 12 weeks ]
- Inflammation [ Time Frame: 12 weeks ]IL-6, IL-8, TNF-alpha, CRP
- Metabolic markers [ Time Frame: 12 weeks ]Glucose, insulin, cholesterol
- QoL assessed by COPD Assessment Test (CAT) [ Time Frame: 12 weeks ]
- QoL assessed by COPD Clinical Questionnaire (CCQ) [ Time Frame: 12 weeks ]
- QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C) [ Time Frame: 12 weeks ]
- QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire [ Time Frame: 12 weeks ]
- QoL assessed by Nutrition Appetite Questionnaire (CNAQ) [ Time Frame: 12 weeks ]
- Compliance assessed by Drinks consumed [ Time Frame: 12 weeks ]
- Compliance assessed by vitamin D levels [ Time Frame: 12 weeks ]
- Compliance assessed by Omega-3 incorporation [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
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

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
Sweden | |
Ladulaas kliniska studier | |
Borås, Sweden, 50630 | |
Pharmasite | |
Helsingborg, Sweden, 25220 | |
Pharmasite | |
Malmö, Sweden, 21152 | |
A+ Science City Site | |
Stockholm, Sweden, 11157 |
Publications:
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: | December 24, 2020 |
Last Verified: | December 2020 |
Wasting Syndrome Cachexia Emaciation Weight Loss |
Body Weight Changes Body Weight Metabolic Diseases Nutrition Disorders |