OverweightPhase 2/3NCT01193543
Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man
A Phase 2/3 study testing calanus oil and olive oil in people with Overweight, run by University of Tromso at 1 site in Norway.
Trial summary
Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and given calanus oli 1 g twice daily versus placebo… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- calanus oil and olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2010to Aug 2012
- Phase
- Phase 2/3
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) 25-30 kg/m2
- age 20-65 years
Who cannot join
- diabetes
- coronary heart disease last 12 months
- unstable angina pectoris
- cancer diagnosed the last 5 years
- use of lipid lowering drugs
- seafood allergy
Trial locations and contacts
1 site in 1 country.
About this study
Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.
- Conditions
- Overweight
- Being tested
- calanus oil, olive oil
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calanus oilDietary supplement
1 gram twice daily
olive oilDietary supplement
1 gram twice daily
| Study group | Role | What they receive |
|---|---|---|
| calanus oil | Experimental | calanus oil 1 gram twice daily Receives: Dietary Supplement: calanus oil |
| olive oil | Placebo comparator | olive oil 1 gram twice daily Receives: Dietary Supplement: olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal fat as measured with CT scan
Measured: at the end of 12 months intervention
Secondary outcomes (5)
oral glucose tolerance test
Measured: at the end of 12 months intervention
lipid status
Measured: at the end of 12 months intervention
systolic and diastolic blood pressure
Measured: at the end of 12 months intervention
markers of inflammation - C-reactive protein (CRP)
Measured: at the end of 12 months intervention
body weight
Measured: at the end of 12 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Jorde, Professor, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193543
- Sponsor's protocol ID
- UIT-ENDO-2010-4
- Status last verified
- Sep 2012
- First submitted
- 1 Sep 2010
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man
- ClinicalTrials.gov ID
- NCT01193543
- Acronym / sponsor ID
- UIT-ENDO-2010-4
- Conditions
- Overweight
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Sep 2010 (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.
Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calanus oil | Experimental | Dietary Supplement: calanus oilcalanus oil 1 gram twice daily |
| olive oil | Placebo comparator | Dietary Supplement: olive oilolive oil 1 gram twice daily |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) 25-30 kg/m2
- age 20-65 years
Key exclusion criteria (6 listed)
- diabetes
- coronary heart disease last 12 months
- unstable angina pectoris
- cancer diagnosed the last 5 years
- use of lipid lowering drugs
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 oil1 gram twice daily | Dietary supplement | calanus oil |
| olive oil1 gram twice daily | Dietary supplement | olive oil |
Primary outcome
Intra-abdominal fat as measured with CT scan
Time frame: at the end of 12 months intervention
5 secondary outcomes
oral glucose tolerance test
Time frame: at the end of 12 months intervention
lipid status
Time frame: at the end of 12 months intervention
systolic and diastolic blood pressure
Time frame: at the end of 12 months intervention
markers of inflammation - C-reactive protein (CRP)
Time frame: at the end of 12 months intervention
body weight
Time frame: at the end of 12 months intervention
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 5 Sep 2012.
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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.
Rolf Jorde, Professor principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing calanus oil and olive oil in people with Overweight, run by University of Tromso at 1 site 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 6 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 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intra-abdominal fat as measured with CT scan (time frame: at the end of 12 months intervention). 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 5 Sep 2012.