HealthyNCT02908828
Calanus Oil Supplementation and Maximal Oxygen Uptake
A study testing Calanus oil in people with Healthy, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Calanus oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2016to 19 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- in good health
- Body mass index (BMI) between 18,5 and 29,9
Who cannot join
- 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
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- Shellfish allergies
- Systolic blood pressure > 170 mmHG, or diastolic BP > 105 mmHG.
- contraindications for maximal exercise testing
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Institutt for Medisinsk Biologi, UiT Norges arktiske universitet
Tromsø
KG Jebsen-senter for Hjertetrening, NTNU
Trondheim
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Calanus oil, placebo dietary oil
- Keywords
- Biological Products/therapeutic use, Copepoda, Dietary Supplements, Fish Oils, Fatty Acids, Omega-3, Oxygen Consumption, Calanus, Maximal oxygen uptake, Zooplankton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calanus oilDietary supplement
placebo dietary oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Calanus oil | Experimental | 4 capsules of 500 mg Calanus oil once every day Receives: Dietary Supplement: Calanus oil |
| Placebo | Placebo comparator | 4 capsules of 500 mg dietary oil once every day Receives: Dietary Supplement: placebo dietary oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Body composition (InBody, Japan)
Measured: 6 months
Self-reported physical activity
assessed with International Physical Activity Questionnaire (IPAQ) short version
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, Calanus
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, phd prof, Study director, Norwegian University of Science and TechnologyTrine Karlsen, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908828
- Sponsor's protocol ID
- 2015/2303
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2016
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Copepod Oil Supplementation (Calanus Finmarchicus) on Endurance and VO2max in Healthy Obese Subjects
- ClinicalTrials.gov ID
- NCT02908828
- Acronym / sponsor ID
- 2015/2303
- Conditions
- Healthy
- Keywords
- Biological Products/therapeutic use, Copepoda, Dietary Supplements, Fish Oils, Fatty Acids, Omega-3, Oxygen Consumption, Calanus, Maximal oxygen uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Tromso, Calanus
- Study start
- Oct 2016 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calanus oil | Experimental | Dietary Supplement: Calanus oil4 capsules of 500 mg Calanus oil once every day |
| Placebo | Placebo comparator | Dietary Supplement: placebo dietary oil4 capsules of 500 mg dietary oil once every day |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- in good health
- Body mass index (BMI) between 18,5 and 29,9
Key exclusion criteria (9 listed)
- Medical condition limiting VO2max (COPD or asthma).
- diagnosed coronary artery disease
- Any other significant medical condition
- medication effecting exercise capacity (e.i. betablockers)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calanus oil | Dietary supplement | Calanus oil |
| placebo dietary oil | Dietary supplement | Placebo |
Primary outcome
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.
2 secondary outcomes
Body composition (InBody, Japan)
Time frame: 6 months
Self-reported physical activity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Wisløff, phd prof study director
Norwegian University of Science and Technology
Trine Karlsen, phd principal investigator
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calanus oil in people with Healthy, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal oxygen uptake (VO2max) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.