n-3 Fatty Acid Effects in T2DM After Acute High Intensity Exercise

June 7, 2017 updated by: Maurício Krause, Federal University of Rio Grande do Sul

Effects of n-3 Fatty Acids and Vitamin E Supplementation Upon Oxidative Stress, Inflammation and Metabolic Parameters in Type 2 Diabetic Subjects at Rest and After an Acute High Intensity Exercise Bout

The aim of this study was to verify the effect of a combined supplementation [n-3 PUFA (known to induce anti-inflammatory effects) plus vitamin E (known for its antioxidant properties)] on lipidic, glycemic, redox status and inflammatory parameters in type 2 diabetic patients. In addition, considering that exercise, at high intensities, can induce a transient inflammatory state and increase oxidative stress (OS) markers, the investigators tested if our nutritional intervention could attenuate this response within this population (thus, using high intensity exercise as inductor of acute inflammatory/OS state).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Herein the investigators tested the effect of eight weeks of omega-3 polyunsaturated fatty acid (n-3 PUFA) and vitamin E supplementation before and after an acute high intensity exercise bout on lipid profile, glycemic, redox and inflammatory parameters in type 2 diabetic (T2DM) patients. Thirty T2DM patients, without chronic complications, took part in this study. Blood and urine samples were collected after 12 h-fasting state for baseline biochemical analysis. Thereafter, subjects performed an incremental workload VO2max test on a cycle ergometer to determine the load of the high intensity submaximal exercise. On the following week, blood samples were collected before and immediately after the exercise test for measurements of oxidative stress (OS) and high-sensitivity C-reactive protein (hs-CRP). Afterwards, participants were randomly allocated into two groups: placebo (gelatin) and n-3 PUFA (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin E). Three capsules were ingested daily for eight weeks. Then, the examination protocol and the exercise test were repeated and the samples collected.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Pôrto Alegre, RS, Brazil, 90035-903
        • Clinical Hospital of Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Type 2 Diabetes
  • Male and female
  • Age between 40 and 60 years old.
  • Must be able to do exercise

Exclusion Criteria:

  • Smoking;
  • Clinical diagnosis of kidney, pulmonary or heart diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: n-3 PUFA Group
Subjects receiving n-3 PUFA (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin E). Three capsules were ingested daily for eight weeks.
Dietary supplement: n-3 PUFA Group
Participants received n-3 PUFA capsules (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin E). Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.
Placebo Comparator: Placebo Group
Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks.
Dietary supplement: Placebo Group
Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on hs-CRP (High-sensitivity C reactive protein)
Time Frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Marker of inflammation expressed in mg/dL
Measured before the supplementation (baseline) and after eight weeks of supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on F2-isoprostanes
Time Frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Marker of oxidative stress expressed in ng/mL
Measured before the supplementation (baseline) and after eight weeks of supplementation
Changes on thiobarbituric acid reactivity
Time Frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Marker of oxidative stress expressed in nmol/mL
Measured before the supplementation (baseline) and after eight weeks of supplementation
Changes on Total Antioxidant activity
Time Frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Marker of oxidative stress expressed in contains per minute
Measured before the supplementation (baseline) and after eight weeks of supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Investigators

  • Study Director: Rogério Friedman, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 10, 2008

Study Completion (Actual)

March 15, 2008

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPA 06-222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data, including body composition, inflammatory and oxidative stress markers and metabolites.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type2 Diabetes Mellitus

Clinical Trials on n-3 PUFA Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe