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

Primary Purpose

Overweight

Status

Completed

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

calanus oil

olive oil

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Tromso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

calanus oil

olive oil

Arm Description

calanus oil 1 gram twice daily

olive oil 1 gram twice daily

Outcomes

Primary Outcome Measures

Intra-abdominal fat as measured with CT scan

Secondary Outcome Measures

oral glucose tolerance test

lipid status

systolic and diastolic blood pressure

markers of inflammation - C-reactive protein (CRP)

body weight

Full Information

NCT ID

NCT01193543

First Posted

September 1, 2010

Last Updated

September 3, 2012

Sponsor

University of Tromso

1. Study Identification

Unique Protocol Identification Number

NCT01193543

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Tromso

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

calanus oil

Arm Type

Experimental

Arm Description

calanus oil 1 gram twice daily

Arm Title

olive oil

Arm Type

Placebo Comparator

Arm Description

olive oil 1 gram twice daily

Intervention Type

Dietary Supplement

Intervention Name(s)

calanus oil

Intervention Description

1 gram twice daily

Intervention Type

Dietary Supplement

Intervention Name(s)

olive oil

Intervention Description

1 gram twice daily

Primary Outcome Measure Information:

Title

Intra-abdominal fat as measured with CT scan

Time Frame