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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01739998
First received: November 27, 2012
Last updated: November 29, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • Anthropometric parameters [ Time Frame: 0.1 and 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, ApoB, ApoA1 and plasma free fatty acids.

  • Hormonal Parameters [ Time Frame: 0.2 months ] [ Designated as safety issue: No ]
    Parameters measured were: Leptin and ghrelin

  • Oxidative Stress Parameters [ Time Frame: 0 and 2 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Parameters measured were: Beck Depression Inventory (BDI).

  • Motivation and Satiety Parameters [ Time Frame: 0 and 2 month ] [ Designated as safety issue: No ]
    Parameters measured were: Visual analogue scale to assess motivation and satiety to eat.

  • Adeherence and Tolerance parameters [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01739998     History of Changes
Other Study ID Numbers: NOBO
Study First Received: November 27, 2012
Last Updated: November 29, 2012
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014