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

NCT ID: NCT01193543

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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calanus oil

calanus oil 1 gram twice daily

Group Type EXPERIMENTAL

calanus oil

Intervention Type DIETARY_SUPPLEMENT

1 gram twice daily

olive oil

olive oil 1 gram twice daily

Group Type PLACEBO_COMPARATOR

olive oil

Intervention Type DIETARY_SUPPLEMENT

1 gram twice daily

Interventions

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calanus oil

1 gram twice daily

Intervention Type DIETARY_SUPPLEMENT

olive oil

1 gram twice daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tromso

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Jorde, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromso

Locations

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University of Tromso

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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UIT-ENDO-2010-4

Identifier Type: -

Identifier Source: org_study_id