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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT01193543
First received: September 1, 2010
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Overweight
 Dietary Supplement: calanus oil
Dietary Supplement: olive oil
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man

Resource links provided by NLM:

Drug Information available for: Olive oil
U.S. FDA Resources

Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Intra-abdominal fat as measured with CT scan [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oral glucose tolerance test [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]
  • lipid status [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]
  • systolic and diastolic blood pressure [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]
  • markers of inflammation - C-reactive protein (CRP) [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: December 2010
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193543

Locations
Norway
University of Tromso
Tromso, Norway, 9037
Sponsors and Collaborators
University of Tromso
Investigators
Principal Investigator: Rolf Jorde, Professor University of Tromso
  More Information

No publications provided

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01193543     History of Changes
Other Study ID Numbers: UIT-ENDO-2010-4
Study First Received: September 1, 2010
Last Updated: September 3, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013