Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man

September 3, 2012 updated by: University of Tromso
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2
  • Phase 3

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
      • Tromso, Norway, 9037
        • University of Tromso

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index (BMI) 25-30 kg/m2
  • age 20-65 years

Exclusion Criteria:

  • diabetes
  • coronary heart disease last 12 months
  • unstable angina pectoris
  • cancer diagnosed the last 5 years
  • use of lipid lowering drugs
  • seafood allergy

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: calanus oil
calanus oil 1 gram twice daily
Dietary supplement: calanus oil
1 gram twice daily
Placebo Comparator: olive oil
olive oil 1 gram twice daily
Dietary supplement: olive oil
1 gram twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra-abdominal fat as measured with CT scan
Time Frame: at the end of 12 months intervention
at the end of 12 months intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
oral glucose tolerance test
Time Frame: at the end of 12 months intervention
at the end of 12 months intervention
lipid status
Time Frame: at the end of 12 months intervention
at the end of 12 months intervention
systolic and diastolic blood pressure
Time Frame: at the end of 12 months intervention
at the end of 12 months intervention
markers of inflammation - C-reactive protein (CRP)
Time Frame: at the end of 12 months intervention
at the end of 12 months intervention
body weight
Time Frame: at the end of 12 months intervention
at the end of 12 months intervention

Collaborators and Investigators

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

Sponsor

University of Tromso

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

December 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIT-ENDO-2010-4

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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