Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Insulin Resistance; Anthropometric Measure; Oxidative Stress; Lipid Profile; Blood Pressure
• Interventions: Dietary Supplement: light fruit jam; Dietary Supplement: microencapsulated fish oil; Dietary Supplement: microencapsulated conjugated linoleic acid

• Registration Number: NCT02183922
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2014-06-27
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-02
• Last Update Submitted: 2014-07-02
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
light fruit jam	light fruit jam	The placebo group received light fruit jam (15 g/day) during 12 weeks.
microencapsulated fish oil	microencapsulated fish oil	The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
microencapsulated conjugated linoleic acid	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.

Primary Outcome Measures

Name	Time	Method
Oxidative stress biomarker	Change from baseline at 12 weeks	Plasma malondialdehyde levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil