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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014