Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2011

Interventions

  • 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.
  • Dietary Supplement: microencapsulated fish oil
    • The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
  • Dietary Supplement: light fruit jam
    • The placebo group received light fruit jam (15 g/day) during 12 weeks.

Arms, Groups and Cohorts

  • Placebo Comparator: 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Oxidative stress biomarker
    • Time Frame: Change from baseline at 12 weeks
    • Plasma malondialdehyde levels

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidade Federal do Rio de Janeiro
  • Collaborator
    • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sofia Kimi Uehara, Doctor – Universidade Federal do Rio de Janeiro
  • Overall Official(s)
    • Sofia Uehara, Nutritionist, Principal Investigator, Universidade Federal do Rio de Janeiro

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