Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tol... | NCT01193543

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

NCT01193543

Sponsor

University of Tromso

Status

Completed

Last Update Posted

Sep 5, 2012Estimated

Enrollment

117Actual

Phase

Phase 2Phase 3

Conditions

Overweight

Interventions

calanus oil
olive oil

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 1, 2010

First Submission Date that Met QC Criteria

Sep 1, 2010

First Posted Date

Sep 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2012

Last Update Posted Date

Sep 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
calanus oil	Experimental	calanus oil 1 gram twice daily	Dietary Supplement: calanus oil
olive oil	Placebo Comparator	olive oil 1 gram twice daily	Dietary Supplement: olive oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
calanus oil	Dietary Supplement	1 gram twice daily	calanus oil
olive oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intra-abdominal fat as measured with CT scan		at the end of 12 months intervention

Secondary Outcomes

Measure	Description	Time Frame
oral glucose tolerance test		at the end of 12 months intervention
lipid status		at the end of 12 months intervention
systolic and diastolic blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rolf Jorde, Professor	University of Tromso	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tromso		Tromsø		9037	Norway

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069463	Olive Oil

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided