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

Primary Purpose

COPD, Cachexia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nutrifriend Cachexia
Isocaloric placebo
Sponsored by
Smartfish AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ladulaas kliniska studier
  • Pharmasite
  • Pharmasite
  • A+ Science City Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NF Cachexia

Placebo

Arm Description

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

An isocaloric placebo comparator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body composition assessed by fat mass and lean body mass (LBM)
Body composition assessed by weight, BMI and waist & calf circumference
Function assessed by 6 minute walking test
Function assessed by grip strength
Function assessed by walking distance
Inflammation
IL-6, IL-8, TNF-alpha, CRP
Metabolic markers
Glucose, insulin, cholesterol
QoL assessed by COPD Assessment Test (CAT)
QoL assessed by COPD Clinical Questionnaire (CCQ)
QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Compliance assessed by Drinks consumed
Compliance assessed by vitamin D levels
Compliance assessed by Omega-3 incorporation

Full Information

First Posted
May 7, 2015
Last Updated
December 22, 2020
Sponsor
Smartfish AS
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1. Study Identification

Unique Protocol Identification Number
NCT02442908
Brief Title
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smartfish AS

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ladulaas kliniska studier
City
Borås
ZIP/Postal Code
50630
Country
Sweden
Facility Name
Pharmasite
City
Helsingborg
ZIP/Postal Code
25220
Country
Sweden
Facility Name
Pharmasite
City
Malmö
ZIP/Postal Code
21152
Country
Sweden
Facility Name
A+ Science City Site
City
Stockholm
ZIP/Postal Code
11157
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28891198
Citation
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.
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Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia

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