Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

NCT02183922 | Completed

• 1 other identifier: 181/10
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Oxidative Stress; Lipid Profile; Blood Pressure; Anthropometric Measure

Outcome Measures

Primary Outcomes (1)

• Oxidative stress biomarker

  Plasma malondialdehyde levels

  Change from baseline at 12 weeks

Secondary Outcomes (5)

• Insulin resistance

  Change from baseline at 12 weeks

• Lipid profile

  Change from baseline at 12 weeks

• Anthropometric measures

  Change from baseline at 12 weeks

• Body composition measures

  Change from baseline at 12 weeks

• Blood pressure

  Change from baseline at 12 weeks

Study Arms (3)

light fruit jam

PLACEBO COMPARATOR

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

Dietary Supplement: light fruit jam

microencapsulated fish oil

EXPERIMENTAL

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

Dietary Supplement: microencapsulated fish oil

microencapsulated conjugated linoleic acid

EXPERIMENTAL

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

Interventions

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 conjugated linoleic acid

microencapsulated fish oil DIETARY_SUPPLEMENT

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

microencapsulated fish oil

light fruit jam DIETARY_SUPPLEMENT

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

light fruit jam

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults women (30-45 years old);
• diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
• Pro12Pro genotype in gene PPARγ2.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-902, Brazil

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sofia Uehara, Nutritionist

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

BR (1)