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

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: functional oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01739998

NOBO

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

functional oil

Experimental group

Description:

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.

Treatment:

Dietary Supplement: functional oil

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo