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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193543
• Other study ID #: UIT-ENDO-2010-4
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 1, 2010
• Last updated: September 3, 2012
• Start date: December 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• calanus oil
1 gram twice daily
• olive oil
1 gram twice daily

Locations

Country	Name	City	State
Norway	University of Tromso	Tromso

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-abdominal fat as measured with CT scan		at the end of 12 months intervention	No
Secondary	oral glucose tolerance test		at the end of 12 months intervention	No
Secondary	lipid status		at the end of 12 months intervention	No
Secondary	systolic and diastolic blood pressure		at the end of 12 months intervention	No
Secondary	markers of inflammation - C-reactive protein (CRP)		at the end of 12 months intervention	No
Secondary	body weight		at the end of 12 months intervention	No