Insulin ResistanceNCT02183922
Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome
A study testing microencapsulated conjugated linoleic acid, microencapsulated fish oil and light fruit jam in people with Insulin Resistance and Oxidative Stress, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype Pro12Pro in the PPAR gamma 2 gene. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Oxidative Stress, Lipid Profile
- What is being tested?
- microencapsulated conjugated linoleic acid, microencapsulated fish oil and light fruit jam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to Jan 2011
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults women (30-45 years old);
- diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
- Pro12Pro genotype in gene PPARγ2.
Who cannot join
- Participants were excluded if they:
- Were allergic to strawberries or fish
- Were pregnant or lactating
- Took fatty acid supplements
- Had undergone bariatric surgery or were being treated nutritionally or pharmacologically for reducing BM, or had taken anti-obesity drugs during the previous three months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-902
About this study
Official title: Hypocaloric Diet With or Without Microencapsulated Fish Oil or Conjugated Linoleic Acid on Oxidative Stress and Cardiovascular Risk Factors in Women With Metabolic Syndrome Genotyped for Polymorphisms in the Genes PPAR Gamma 2 (Pro12Ala) and Adiponectin (G276T)
Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype Pro12Pro in the PPAR gamma 2 gene.
- Conditions
- Insulin Resistance, Oxidative Stress, Lipid Profile, Blood Pressure, Anthropometric Measure
- Being tested
- microencapsulated conjugated linoleic acid, microencapsulated fish oil, light fruit jam
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microencapsulated conjugated linoleic acidDietary supplement
The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.
microencapsulated fish oilDietary supplement
The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
light fruit jamDietary supplement
The placebo group received light fruit jam (15 g/day) during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| light fruit jam | Placebo comparator | The placebo group received light fruit jam (15 g/day) during 12 weeks. Receives: Dietary Supplement: light fruit jam |
| microencapsulated fish oil | Experimental | The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks. Receives: Dietary Supplement: microencapsulated fish oil |
| microencapsulated conjugated linoleic acid | Experimental | The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks. Receives: Dietary Supplement: microencapsulated conjugated linoleic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress biomarker
Plasma malondialdehyde levels
Measured: Change from baseline at 12 weeks
Secondary outcomes (5)
Insulin resistance
Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels
Measured: Change from baseline at 12 weeks
Lipid profile
Total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol and triglycerides serum levels and EPA, DHA and total conjugated linoleic acid plasma levels
Measured: Change from baseline at 12 weeks
Anthropometric measures
Body weight, body mass index and waist circumference
Measured: Change from baseline at 12 weeks
Body composition measures
Fat-free mass and fat mass
Measured: Change from baseline at 12 weeks
Blood pressure
Systolic blood pressure and diastolic blood pressure
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Sofia Kimi Uehara, Universidade Federal do Rio de Janeiro
- Investigators
- Sofia Uehara, Nutritionist, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183922
- Sponsor's protocol ID
- 181/10
- Status last verified
- Jul 2014
- First submitted
- 27 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypocaloric Diet With or Without Microencapsulated Fish Oil or Conjugated Linoleic Acid on Oxidative Stress and Cardiovascular Risk Factors in Women With Metabolic Syndrome Genotyped for Polymorphisms in the Genes PPAR Gamma 2 (Pro12Ala) and Adiponectin (G276T)
- ClinicalTrials.gov ID
- NCT02183922
- Acronym / sponsor ID
- 181/10
- Conditions
- Insulin Resistance, Oxidative Stress, Lipid Profile, Blood Pressure, Anthropometric Measure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- May 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Jul 2014 (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.
Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype Pro12Pro in the PPAR gamma 2 gene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| light fruit jam | Placebo comparator | Dietary Supplement: light fruit jamThe placebo group received light fruit jam (15 g/day) during 12 weeks. |
| microencapsulated fish oil | Experimental | Dietary Supplement: microencapsulated fish oilThe microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks. |
| microencapsulated conjugated linoleic acid | Experimental | Dietary Supplement: microencapsulated conjugated linoleic acidThe microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults women (30-45 years old);
- diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
- Pro12Pro genotype in gene PPARγ2.
Key exclusion criteria (5 listed)
- Were allergic to strawberries or fish
- Were pregnant or lactating
- Took fatty acid supplements
- Had undergone bariatric surgery or were being treated nutritionally or pharmacologically for reducing BM, or had taken anti-obesity drugs during the previous three months
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 |
|---|---|---|
| microencapsulated conjugated linoleic acidThe microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks. | Dietary supplement | microencapsulated conjugated linoleic acid |
| microencapsulated fish oilThe microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks. | Dietary supplement | microencapsulated fish oil |
| light fruit jamThe placebo group received light fruit jam (15 g/day) during 12 weeks. | Dietary supplement | light fruit jam |
Primary outcome
Oxidative stress biomarker
Time frame: Change from baseline at 12 weeks
Plasma malondialdehyde levels
5 secondary outcomes
Insulin resistance
Time frame: Change from baseline at 12 weeks
Lipid profile
Time frame: Change from baseline at 12 weeks
Anthropometric measures
Time frame: Change from baseline at 12 weeks
Body composition measures
Time frame: Change from baseline at 12 weeks
Blood pressure
Time frame: Change from baseline at 12 weeks
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 8 Jul 2014.
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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.
Sofia Uehara, Nutritionist principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microencapsulated conjugated linoleic acid, microencapsulated fish oil and light fruit jam in people with Insulin Resistance and Oxidative Stress, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 5 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Oxidative stress biomarker (time frame: Change from baseline at 12 weeks). 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 8 Jul 2014.