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

Phase 4

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: functional oil

• Registration Number: NCT01739998
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-11
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Study First Posted: 2012-12-04
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treatment consisted of consuming 5 ml of olive oil during the day by 8 weeks
functional oil	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.

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	2 months	Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR

Secondary Outcome Measures

Name	Time	Method
Anthropometric parameters	0.1 and 2 months	Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%).
Lipid profile	0.1 and 2 months	Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, ApoB, ApoA1 and plasma free fatty acids.
Hormonal Parameters	0.2 months	Parameters measured were: Leptin and ghrelin
Oxidative Stress Parameters	0 and 2 months	Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay).
Glucosa Metabolism	0, 1 and 2 months	Parameters measured were: glucose, basal insulin, HbA1c (in diabetic patients), HOMA index (glucemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5).
Depression Test	0 and 2 months	Parameters measured were: Beck Depression Inventory (BDI).
Motivation and Satiety Parameters	0 and 2 month	Parameters measured were: Visual analogue scale to assess motivation and satiety to eat.
Adeherence and Tolerance parameters	up to 2 months	Questionnaire of adherence and tolerance to the product.