NCT02908828

Brief Summary

Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton species in the marine food web in the Norwegian Sea. Copepods constitute the largest renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now developed knowledge and technology for sustainable harvesting of this "new" resource. The purpose of this study is to investigate whether Calanus copepod oil supplementation has an equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in mice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

September 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

September 14, 2016

Last Update Submit

September 29, 2020

Conditions

Healthy

Keywords

Biological Products/therapeutic useCopepodaDietary SupplementsFish OilsFatty Acids, Omega-3Oxygen ConsumptionCalanusMaximal oxygen uptakeZooplankton

Outcome Measures

Primary Outcomes (1)

  • maximal oxygen uptake (VO2max)

    Measured with indirect calorimetry at a treadmill (running/walking) with gradually increasing work load until exhaustion. After 10-15 min with warmup at 70% of maximal heart rate, work load will be increased every 1-2 minute and the changes maximal oxygen uptake (VO2) will be recorded automatically.

    6 months

Secondary Outcomes (2)

  • Body composition (InBody, Japan)

    6 months

  • Self-reported physical activity

    6 months

Study Arms (2)

Calanus oil

EXPERIMENTAL

4 capsules of 500 mg Calanus oil once every day

Dietary Supplement: Calanus oil

Placebo

PLACEBO COMPARATOR

4 capsules of 500 mg dietary oil once every day

Dietary Supplement: placebo dietary oil

Interventions

Calanus oilDIETARY_SUPPLEMENT
Calanus oil
placebo dietary oilDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • in good health
  • Body mass index (BMI) between 18,5 and 29,9

You may not qualify if:

  • Medical condition limiting VO2max (COPD or asthma).
  • diagnosed coronary artery disease
  • Any other significant medical condition
  • medication effecting exercise capacity (e.i. betablockers)
  • Pregnancy
  • Participation in other clinical trials
  • Shellfish allergies
  • Systolic blood pressure \> 170 mmHG, or diastolic BP \> 105 mmHG.
  • contraindications for maximal exercise testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institutt for Medisinsk Biologi, UiT Norges arktiske universitet

Tromsø, Norway

Location

KG Jebsen-senter for Hjertetrening, NTNU

Trondheim, Norway

Location

Study Officials

  • Ulrik Wisløff, phd prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

  • Trine Karlsen, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 21, 2016

Study Start

October 1, 2016

Primary Completion

September 19, 2017

Study Completion

September 19, 2017

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

NO(2)