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Trial record 2 of 37 for:    conjugated linoleic acid

Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02183922
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Sofia Kimi Uehara, Universidade Federal do Rio de Janeiro

Brief 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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Oxidative Stress Lipid Profile Blood Pressure Anthropometric Measure Dietary Supplement: microencapsulated conjugated linoleic acid Dietary Supplement: microencapsulated fish oil Dietary Supplement: light fruit jam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : May 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: light fruit jam
The placebo group received light fruit jam (15 g/day) during 12 weeks.
Dietary Supplement: light fruit jam
The placebo group received light fruit jam (15 g/day) during 12 weeks.

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

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




Primary Outcome Measures :
  1. Oxidative stress biomarker [ Time Frame: Change from baseline at 12 weeks ]
    Plasma malondialdehyde levels


Secondary Outcome Measures :
  1. Insulin resistance [ Time Frame: Change from baseline at 12 weeks ]
    Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels

  2. Lipid profile [ Time Frame: Change from baseline at 12 weeks ]
    Total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol and triglycerides serum levels and EPA, DHA and total conjugated linoleic acid plasma levels

  3. Anthropometric measures [ Time Frame: Change from baseline at 12 weeks ]
    Body weight, body mass index and waist circumference

  4. Body composition measures [ Time Frame: Change from baseline at 12 weeks ]
    Fat-free mass and fat mass

  5. Blood pressure [ Time Frame: Change from baseline at 12 weeks ]
    Systolic blood pressure and diastolic blood pressure



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183922


Locations
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Brazil
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 21941-902
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
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Principal Investigator: Sofia Uehara, Nutritionist Universidade Federal do Rio de Janeiro

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Responsible Party: Sofia Kimi Uehara, Doctor, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02183922     History of Changes
Other Study ID Numbers: 181/10
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases