COPDNCT02442908
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
A study testing Nutrifriend Cachexia in people with COPD and Cachexia, run by Smartfish AS at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Nutrifriend Cachexia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesSweden
- Study dates
- May 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Ladulaas kliniska studier
Borås, 50630
Pharmasite
Helsingborg, 25220
Pharmasite
Malmö, 21152
A+ Science City Site
Stockholm, 11157
About this study
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)
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.
Read the 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.
- Being tested
- Nutrifriend Cachexia, Isocaloric placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrifriend CachexiaDietary supplement
Also called NFCax
2 daily for 12 weeks
Isocaloric placeboDietary supplement
Also called Placobo
2 daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| NF Cachexia | Experimental | Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula). Receives: Dietary Supplement: Nutrifriend Cachexia |
| Placebo | Placebo comparator | An isocaloric placebo comparator Receives: Dietary Supplement: Isocaloric placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
Measured: 12 weeks
Secondary outcomes (15)
Body composition assessed by fat mass and lean body mass (LBM)
Measured: 12 weeks
Body composition assessed by weight, BMI and waist & calf circumference
Measured: 12 weeks
Function assessed by 6 minute walking test
Measured: 12 weeks
Function assessed by grip strength
Measured: 12 weeks
Function assessed by walking distance
Measured: 12 weeks
Inflammation
IL-6, IL-8, TNF-alpha, CRP
Measured: 12 weeks
Metabolic markers
Glucose, insulin, cholesterol
Measured: 12 weeks
QoL assessed by COPD Assessment Test (CAT)
Measured: 12 weeks
QoL assessed by COPD Clinical Questionnaire (CCQ)
Measured: 12 weeks
QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)
Measured: 12 weeks
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Measured: 12 weeks
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Measured: 12 weeks
Compliance assessed by Drinks consumed
Measured: 12 weeks
Compliance assessed by vitamin D levels
Measured: 12 weeks
Compliance assessed by Omega-3 incorporation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smartfish AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442908
- Sponsor's protocol ID
- SF-K002
- Status last verified
- Dec 2020
- First submitted
- 7 May 2015
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Ohlander 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.
PubMed 28891198
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02442908
- Acronym / sponsor ID
- SF-K002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Smartfish ASIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NF Cachexia | Experimental | Dietary Supplement: Nutrifriend CachexiaNutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula). |
| Placebo | Placebo comparator | Dietary Supplement: Isocaloric placeboAn isocaloric placebo comparator |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrifriend CachexiaAlso: NFCax2 daily for 12 weeks | Dietary supplement | NF Cachexia |
| Isocaloric placeboAlso: Placobo2 daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
Time frame: 12 weeks
15 secondary outcomes
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
Metabolic markers
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Background: PubMed 28891198Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Ohlander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrifriend Cachexia in people with COPD and Cachexia, run by Smartfish AS at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.