Health Benefits of Functional Oil (Mega 3 Fatty Acids From Fish Oil) on Obese People (NOBO)
This study has been completed.
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
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
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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 May 16, 2013