Calanus Oil Supplementation and Maximal Oxygen Uptake

September 29, 2020 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway
        • Institutt for Medisinsk Biologi, UiT Norges arktiske universitet
      • Trondheim, Norway
        • KG Jebsen-senter for Hjertetrening, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal oxygen uptake (VO2max)
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition (InBody, Japan)
Time Frame: 6 months
6 months
Self-reported physical activity
Time Frame: 6 months
assessed with International Physical Activity Questionnaire (IPAQ) short version
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

University of Tromso
Calanus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

September 19, 2017

Study Completion (Actual)

September 19, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 17, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015/2303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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