ObesityPhase 4NOBONCT01739998
Health Benefits of Functional Oil (Mega 3 Fatty Acids From Fish Oil) on Obese People
A Phase 4 study testing functional oil in people with Obesity, run by Instituto de Investigación Hospital Universitario La Paz.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- functional oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women from 30 to 75 years old.
- Body mass index (BMI) ≥ 30 kg/m2
- Signed informed consent.
Who cannot join
- 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).
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- 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.
About this study
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
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
- Being tested
- functional oil, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional oilDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: functional oil |
| Placebo | Placebo comparator | Treatment consisted of consuming 5 ml of olive oil during the day by 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR
Measured: 2 months
Secondary outcomes (8)
Anthropometric parameters
Parameters measured were: Weight, Height and waist circumference, muscle mass percentage (MM%), fat mass percentage (FM%).
Measured: 0.1 and 2 months
Lipid profile
Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, ApoB, ApoA1 and plasma free fatty acids.
Measured: 0.1 and 2 months
Hormonal Parameters
Parameters measured were: Leptin and ghrelin
Measured: 0.2 months
Oxidative Stress Parameters
Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay).
Measured: 0 and 2 months
Glucosa Metabolism
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).
Measured: 0, 1 and 2 months
Depression Test
Parameters measured were: Beck Depression Inventory (BDI).
Measured: 0 and 2 months
Motivation and Satiety Parameters
Parameters measured were: Visual analogue scale to assess motivation and satiety to eat.
Measured: 0 and 2 month
Adeherence and Tolerance parameters
Questionnaire of adherence and tolerance to the product.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739998
- Sponsor's protocol ID
- NOBO
- Acronym
- NOBO
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01739998
- Acronym / sponsor ID
- NOBO / NOBO
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional oil | Experimental | Dietary Supplement: functional oilTreatment 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTreatment consisted of consuming 5 ml of olive oil during the day by 8 weeks |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women from 30 to 75 years old.
- Body mass index (BMI) ≥ 30 kg/m2
- Signed informed consent.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional oil | Dietary supplement | functional oil |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Inflammatory markers
Time frame: 2 months
Inflammatory markers (Adiponectin, fibrinogen, TNFα, PAI-1 and PCR
8 secondary outcomes
Anthropometric parameters
Time frame: 0.1 and 2 months
Lipid profile
Time frame: 0.1 and 2 months
Hormonal Parameters
Time frame: 0.2 months
Oxidative Stress Parameters
Time frame: 0 and 2 months
Glucosa Metabolism
Time frame: 0, 1 and 2 months
Depression Test
Time frame: 0 and 2 months
Motivation and Satiety Parameters
Time frame: 0 and 2 month
Adeherence and Tolerance parameters
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing functional oil in people with Obesity, run by Instituto de Investigación Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.