Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

Study Overview
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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.

Official Title
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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)

Conditions
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Lipid Profile, Blood Pressure, Anthropometric Measure, Insulin Resistance, Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: microencapsulated conjugated linoleic acid
* Dietary Supplement: microencapsulated fish oil
* Dietary Supplement: light fruit jam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: light fruit jam<br>The placebo group received light fruit jam (15 g/day) during 12 weeks. | Dietary Supplement: light fruit jam<br>* The placebo group received light fruit jam (15 g/day) during 12 weeks.<br>|
| Experimental: microencapsulated fish oil<br>The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks. | Dietary Supplement: microencapsulated fish oil<br>* The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.<br>|
| Experimental: microencapsulated conjugated linoleic acid<br>The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks. | Dietary Supplement: microencapsulated conjugated linoleic acid<br>* The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress biomarker | Plasma malondialdehyde levels | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels | 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 | Change from baseline at 12 weeks | 
| Anthropometric measures | Body weight, body mass index and waist circumference | Change from baseline at 12 weeks | 
| Body composition measures | Fat-free mass and fat mass | Change from baseline at 12 weeks | 
| Blood pressure | Systolic blood pressure and diastolic blood pressure | Change from baseline at 12 weeks |