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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

September 1, 2010
September 3, 2012
December 2010
June 2012   (final data collection date for primary outcome measure)
Intra-abdominal fat as measured with CT scan [ Time Frame: at the end of 12 months intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01193543 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man
Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overweight
  • Dietary Supplement: calanus oil
    1 gram twice daily
  • Dietary Supplement: olive oil
    1 gram twice daily
  • Experimental: calanus oil
    calanus oil 1 gram twice daily
    Intervention: Dietary Supplement: calanus oil
  • Placebo Comparator: olive oil
    olive oil 1 gram twice daily
    Intervention: Dietary Supplement: olive oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
August 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01193543
UIT-ENDO-2010-4
No
University of Tromso
University of Tromso
Not Provided
Principal Investigator: Rolf Jorde, Professor University of Tromso
University of Tromso
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP