We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739998
First Posted: December 4, 2012
Last Update Posted: December 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
  Purpose
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
Obesity Dietary Supplement: functional oil Dietary Supplement: Placebo Phase 4

Study Type: Interventional
Study Design: 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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01739998     History of Changes
Other Study ID Numbers: NOBO
First Submitted: November 27, 2012
First Posted: December 4, 2012
Last Update Posted: December 4, 2012
Last Verified: November 2012