Health Benefits of Functional Oil (Mega 3 Fatty Acids From Fish Oil) on Obese People

NCT ID: NCT01739998

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-03-31

Brief Summary

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Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from fish oil) on different inflammatory markers in obese subjects with dietary intervention for weight lost.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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functional oil

Treatment consisted of consuming 5 ml of functional oil \[olive oil (4 ml) with omega 3 fatty acids from fish oil (1 ml: 90% omega 3: 75-80% DHA and 10-15% EPA) Orange flavour\] during the day by 8 weeks.

Group Type EXPERIMENTAL

functional oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Treatment consisted of consuming 5 ml of olive oil during the day by 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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functional oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Men and women from 30 to 75 years old.
* Body mass index (BMI) ≥ 30 kg/m2
* Signed informed consent.

Exclusion Criteria

* Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
* Individuals with Diabetes Mellitus insulin dependent.
* Individuals with disorders associated with eating behaviour.
* Individuals with mental disease or low cognitive function.
* Individuals with consumption of drugs to weight lost.
* Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
* Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.)
* Pregnant women or lactating.
* Individuals with recurrent infections.
* Individuals with regular consumption of anti-inflammatory or glucocorticoids.
* Individuals with consumption of oil fish supplements (except if they gave up its consumption 1 month before).
* Individuals with fish allergy.
* Individuals with consumption of more than two fatty fish servers twice a week.
* Individuals with physical problems complying with the recommendations of physical activity and diet indicated.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NOBO

Identifier Type: -

Identifier Source: org_study_id