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Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

Primary Purpose

Insulin Resistance, Oxidative Stress, Lipid Profile

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
microencapsulated conjugated linoleic acid
microencapsulated fish oil
light fruit jam
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

30 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Federal do Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

light fruit jam

microencapsulated fish oil

microencapsulated conjugated linoleic acid

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Oxidative stress biomarker
Plasma malondialdehyde levels

Secondary Outcome Measures

Insulin resistance
Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels
Lipid profile
Total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol and triglycerides serum levels and EPA, DHA and total conjugated linoleic acid plasma levels
Anthropometric measures
Body weight, body mass index and waist circumference
Body composition measures
Fat-free mass and fat mass
Blood pressure
Systolic blood pressure and diastolic blood pressure

Full Information

First Posted
June 27, 2014
Last Updated
July 2, 2014
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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1. Study Identification

Unique Protocol Identification Number
NCT02183922
Brief Title
Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Oxidative Stress, Lipid Profile, Blood Pressure, Anthropometric Measure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
light fruit jam
Arm Type
Placebo Comparator
Arm Description
The placebo group received light fruit jam (15 g/day) during 12 weeks.
Arm Title
microencapsulated fish oil
Arm Type
Experimental
Arm Description
The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
Arm Title
microencapsulated conjugated linoleic acid
Arm Type
Experimental
Arm Description
The microencapsulated conjugated linoleic acid group received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
microencapsulated conjugated linoleic acid
Intervention Description
The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
microencapsulated fish oil
Intervention Description
The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
light fruit jam
Intervention Description
The placebo group received light fruit jam (15 g/day) during 12 weeks.
Primary Outcome Measure Information:
Title
Oxidative stress biomarker
Description
Plasma malondialdehyde levels
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Insulin resistance
Description
Homeostatic Model Assessment-Insulin Resistance index, adiponectin, glucose and insulin levels
Time Frame
Change from baseline at 12 weeks
Title
Lipid profile
Description
Total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol and triglycerides serum levels and EPA, DHA and total conjugated linoleic acid plasma levels
Time Frame
Change from baseline at 12 weeks
Title
Anthropometric measures
Description
Body weight, body mass index and waist circumference
Time Frame
Change from baseline at 12 weeks
Title
Body composition measures
Description
Fat-free mass and fat mass
Time Frame
Change from baseline at 12 weeks
Title
Blood pressure
Description
Systolic blood pressure and diastolic blood pressure
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Uehara, Nutritionist
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-902
Country
Brazil

12. IPD Sharing Statement

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Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

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