NCT02442908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

May 7, 2015

Last Update Submit

December 22, 2020

Conditions

COPDCachexia

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD

    12 weeks

Secondary Outcomes (15)

  • Body composition assessed by fat mass and lean body mass (LBM)

    12 weeks

  • Body composition assessed by weight, BMI and waist & calf circumference

    12 weeks

  • Function assessed by 6 minute walking test

    12 weeks

  • Function assessed by grip strength

    12 weeks

  • Function assessed by walking distance

    12 weeks

  • +10 more secondary outcomes

Study Arms (2)

NF Cachexia

EXPERIMENTAL

Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).

Dietary Supplement: Nutrifriend Cachexia

Placebo

PLACEBO COMPARATOR

An isocaloric placebo comparator

Dietary Supplement: Isocaloric placebo

Interventions

Nutrifriend CachexiaDIETARY_SUPPLEMENT

2 daily for 12 weeks

Also known as: NFCax
NF Cachexia
Isocaloric placeboDIETARY_SUPPLEMENT

2 daily for 12 weeks

Also known as: Placobo
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>50 years
  • Moderate to severe COPD patients with forced expiratory volume (FEV1) of 30-60%
  • Involuntary weight loss \<10%
  • kg/m2 ≤ BMI ≤ 32 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ladulaas kliniska studier

Borås, 50630, Sweden

Location

Pharmasite

Helsingborg, 25220, Sweden

Location

Pharmasite

Malmo, 21152, Sweden

Location

A+ Science City Site

Stockholm, 11157, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 28891198BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCachexia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinness

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 13, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

SE(4)