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

University of Tromso (UiT)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overweight

Treatments: Dietary Supplement: olive oil; Dietary Supplement: calanus oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01193543

UIT-ENDO-2010-4

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

calanus oil

Experimental group

Description:

calanus oil 1 gram twice daily

Treatment:

Dietary Supplement: calanus oil

olive oil

Placebo Comparator group

Description:

olive oil 1 gram twice daily

Treatment:

Dietary Supplement: olive oil