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Completed

NCT Number: NCT02183922

Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

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.

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Key information

Conditions

Insulin Resistance Anthropometric Measure Blood Pressure Glucose Metabolism Disorders Hyperinsulinism Lipid Profile Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941-902, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microencapsulated conjugated linoleic acid

Dietary Supplement

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

microencapsulated fish oil

Dietary Supplement

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

light fruit jam

Dietary Supplement

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

Primary outcomes

  1. Oxidative stress biomarker

    Time frame: Change from baseline at 12 weeks

    Plasma malondialdehyde levels

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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