Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTfunctional oil
DIETARY_SUPPLEMENTPlacebo
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers | 2 months | Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Anthropometric parameters | 0.1 and 2 months | Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%). |
| 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. |
| 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). |
Outcome results
None listed