Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

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)

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Blood Pressure; Oxidative Stress; Lipid Profile; Anthropometric Measure
• Intervention / Treatment: Dietary supplement: light fruit jam; Dietary supplement: microencapsulated fish oil; Dietary supplement: microencapsulated conjugated linoleic acid

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21941-902
    • Universidade Federal do Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Principal Investigator: Sofia Uehara, Nutritionist, Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: 181/10