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Completed

NCT Number: NCT01739998

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

functional oil

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Inflammatory markers

    Time frame: 2 months

    Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR

Secondary outcomes

  1. Anthropometric parameters

    Time frame: 0.1 and 2 months

    Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%).

  2. Lipid profile

    Time frame: 0.1 and 2 months

    Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, ApoB, ApoA1 and plasma free fatty acids.

  3. Hormonal Parameters

    Time frame: 0.2 months

    Parameters measured were: Leptin and ghrelin

  4. Oxidative Stress Parameters

    Time frame: 0 and 2 months

    Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay).

  5. Glucosa Metabolism

    Time frame: 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).

  6. Depression Test

    Time frame: 0 and 2 months

    Parameters measured were: Beck Depression Inventory (BDI).

  7. Motivation and Satiety Parameters

    Time frame: 0 and 2 month

    Parameters measured were: Visual analogue scale to assess motivation and satiety to eat.

  8. Adeherence and Tolerance parameters

    Time frame: up to 2 months

    Questionnaire of adherence and tolerance to the product.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study 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

Acronym: NOBO

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 4, 2012
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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