Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

NCT ID: NCT02183922

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance Oxidative Stress Lipid Profile Blood Pressure Anthropometric Measure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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light fruit jam

The placebo group received light fruit jam (15 g/day) during 12 weeks.

Group Type PLACEBO_COMPARATOR

light fruit jam

Intervention Type DIETARY_SUPPLEMENT

The placebo group received light fruit jam (15 g/day) during 12 weeks.

microencapsulated fish oil

The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.

Group Type EXPERIMENTAL

microencapsulated fish oil

Intervention Type DIETARY_SUPPLEMENT

The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.

microencapsulated conjugated linoleic acid

The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.

Group Type EXPERIMENTAL

microencapsulated conjugated linoleic acid

Intervention Type DIETARY_SUPPLEMENT

The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.

Interventions

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microencapsulated conjugated linoleic acid

The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

microencapsulated fish oil

The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

light fruit jam

The placebo group received light fruit jam (15 g/day) during 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* adults women (30-45 years old);
* diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
* Pro12Pro genotype in gene PPARγ2.

Exclusion Criteria

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Sofia Kimi Uehara

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sofia Uehara, Nutritionist

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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181/10

Identifier Type: -

Identifier Source: org_study_id

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