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

Study Overview
=================
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.

Official Title
-----------------
Randomized, Double-blind, Controlled Study to Evaluate the Efficacy of Omega 3 Fatty Acids on Different Inflammatory Markers in Obese Subjects With Dietary Intervention for Weight Lost

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: functional oil
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: functional oil<br>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. | Dietary Supplement: functional oil<br> <br> |
| Placebo Comparator: Placebo<br>Treatment consisted of consuming 5 ml of olive oil during the day by 8 weeks | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric parameters | Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%). | 0.1 and 2 months | 
| Lipid profile | Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, ApoB, ApoA1 and plasma free fatty acids. | 0.1 and 2 months | 
| Hormonal Parameters | Parameters measured were: Leptin and ghrelin | 0.2 months | 
| Oxidative Stress Parameters | Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay). | 0 and 2 months | 
| Glucosa Metabolism | 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). | 0, 1 and 2 months | 
| Depression Test | Parameters measured were: Beck Depression Inventory (BDI). | 0 and 2 months | 
| Motivation and Satiety Parameters | Parameters measured were: Visual analogue scale to assess motivation and satiety to eat. | 0 and 2 month | 
| Adeherence and Tolerance parameters | Questionnaire of adherence and tolerance to the product. | up to 2 months |