Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz Identifier:
First received: November 27, 2012
Last updated: November 29, 2012
Last verified: November 2012
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 Intervention Phase
Dietary Supplement: functional oil
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

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

Secondary Outcome Measures:
  • 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%).

  • 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.

  • Hormonal Parameters [ Time Frame: 0.2 months ]
    Parameters measured were: Leptin and ghrelin

  • 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).

  • 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).

  • Depression Test [ Time Frame: 0 and 2 months ]
    Parameters measured were: Beck Depression Inventory (BDI).

  • Motivation and Satiety Parameters [ Time Frame: 0 and 2 month ]
    Parameters measured were: Visual analogue scale to assess motivation and satiety to eat.

  • Adeherence and Tolerance parameters [ Time Frame: up to 2 months ]
    Questionnaire of adherence and tolerance to the product.

Enrollment: 52
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Instituto de Investigación Hospital Universitario La Paz Identifier: NCT01739998     History of Changes
Other Study ID Numbers: NOBO
Study First Received: November 27, 2012
Last Updated: November 29, 2012 processed this record on May 23, 2017