Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

Insulin Resistance Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183922
• Other study ID #: 181/10
• Status: Completed
• Phase: N/A
• First received: June 27, 2014
• Last updated: July 2, 2014
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: July 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

Inclusion Criteria:

• adults women (30-45 years old);

• diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;

• Pro12Pro genotype in gene PPAR?2.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anthropometric Measure
• Blood Pressure
• Insulin Resistance
• Lipid Profile
• Metabolic Syndrome X
• Oxidative Stress

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress biomarker	Plasma malondialdehyde levels	Change from baseline at 12 weeks	Yes
Secondary	Insulin resistance	Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels	Change from baseline at 12 weeks	Yes
Secondary	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	Yes
Secondary	Anthropometric measures	Body weight, body mass index and waist circumference	Change from baseline at 12 weeks	Yes
Secondary	Body composition measures	Fat-free mass and fat mass	Change from baseline at 12 weeks	Yes
Secondary	Blood pressure	Systolic blood pressure and diastolic blood pressure	Change from baseline at 12 weeks	Yes