Calanus Oil Supplementation and Maximal Oxygen Uptake

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02908828

Collaborator

University of Tromso (Other), Calanus (Industry)

Enrollment

Locations

Arms

11.6

Actual Duration (Months)

35.5

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Calanus oil Dietary Supplement: placebo dietary oil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Copepod Oil Supplementation (Calanus Finmarchicus) on Endurance and VO2max in Healthy Obese Subjects

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Sep 19, 2017

Actual Study Completion Date :

Sep 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calanus oil 4 capsules of 500 mg Calanus oil once every day	Dietary Supplement: Calanus oil
Placebo Comparator: Placebo 4 capsules of 500 mg dietary oil once every day	Dietary Supplement: placebo dietary oil

Arm

Intervention/Treatment

Experimental: Calanus oil

4 capsules of 500 mg Calanus oil once every day

Dietary Supplement: Calanus oil

Placebo Comparator: Placebo

4 capsules of 500 mg dietary oil once every day

Dietary Supplement: placebo dietary oil

Outcome Measures

Primary Outcome Measures

maximal oxygen uptake (VO2max) [6 months]
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.

Secondary Outcome Measures

Body composition (InBody, Japan) [6 months]
Self-reported physical activity [6 months]
assessed with International Physical Activity Questionnaire (IPAQ) short version

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institutt for Medisinsk Biologi, UiT Norges arktiske universitet	Tromsø		Norway
2	KG Jebsen-senter for Hjertetrening, NTNU	Trondheim		Norway

Sponsors and Collaborators

Norwegian University of Science and Technology
University of Tromso
Calanus

Investigators

Study Director: Ulrik Wisløff, phd prof, Norwegian University of Science and Technology
Principal Investigator: Trine Karlsen, phd, Norwegian University of Science and Technology