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

NCT01739998 | Completed Phase 4

• 1 other identifier: NOBO
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Inflammatory markers

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

  2 months

Secondary Outcomes (8)

• Anthropometric parameters

  0.1 and 2 months

• Lipid profile

  0.1 and 2 months

• Hormonal Parameters

  0.2 months

• Oxidative Stress Parameters

  0 and 2 months

• Glucosa Metabolism

  0, 1 and 2 months

Study Arms (2)

functional oil

EXPERIMENTAL

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

PLACEBO COMPARATOR

Treatment consisted of consuming 5 ml of olive oil during the day by 8 weeks

Dietary Supplement: Placebo

Interventions

functional oil DIETARY_SUPPLEMENT

functional oil

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women from 30 to 75 years old.
• Body mass index (BMI) ≥ 30 kg/m2
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

MeSH Terms

Conditions

Obesity

Interventions

Functional Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 4, 2012

Record last verified: 2012-11