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OpenTrials
Completed

NCT Number: NCT01193543

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Tromso

Tromsø, 9037, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calanus oil

Dietary Supplement

1 gram twice daily

Olive Oil

Dietary Supplement

1 gram twice daily

Primary outcomes

  1. Intra-abdominal fat as measured with CT scan

    Time frame: at the end of 12 months intervention

Secondary outcomes

  1. oral glucose tolerance test

    Time frame: at the end of 12 months intervention

  2. lipid status

    Time frame: at the end of 12 months intervention

  3. systolic and diastolic blood pressure

    Time frame: at the end of 12 months intervention

  4. markers of inflammation - C-reactive protein (CRP)

    Time frame: at the end of 12 months intervention

  5. body weight

    Time frame: at the end of 12 months intervention

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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