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

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ClinicalTrials.gov Identifier: NCT01739998
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: functional oil Dietary Supplement: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
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
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: functional oil
Placebo Comparator: Placebo
Treatment consisted of consuming 5 ml of olive oil during the day by 8 weeks
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 2 months ]
    Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01739998     History of Changes
Other Study ID Numbers: NOBO
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012