Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man
1 other identifier
interventional
117
1 country
1
Brief 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 for 1 year. The hypothesis is that calanus oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 5, 2012
September 1, 2012
1.5 years
September 1, 2010
September 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Intra-abdominal fat as measured with CT scan
at the end of 12 months intervention
Secondary Outcomes (5)
oral glucose tolerance test
at the end of 12 months intervention
lipid status
at the end of 12 months intervention
systolic and diastolic blood pressure
at the end of 12 months intervention
markers of inflammation - C-reactive protein (CRP)
at the end of 12 months intervention
body weight
at the end of 12 months intervention
Study Arms (2)
calanus oil
EXPERIMENTALcalanus oil 1 gram twice daily
olive oil
PLACEBO COMPARATORolive oil 1 gram twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) 25-30 kg/m2
- age 20-65 years
You may not qualify if:
- diabetes
- coronary heart disease last 12 months
- unstable angina pectoris
- cancer diagnosed the last 5 years
- use of lipid lowering drugs
- seafood allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tromso
Tromsø, 9037, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf Jorde, Professor
University of Tromso
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 2, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
September 5, 2012
Record last verified: 2012-09