Clinical Trials Directory

Trials / Completed

CompletedNCT03182712

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Federal University of Rio Grande do Sul · Academic / Other
Sex
All
Age
40 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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).

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTn-3 PUFA GroupParticipants 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.
DIETARY_SUPPLEMENTPlacebo GroupParticipants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.

Timeline

Start date
2007-02-01
Primary completion
2008-02-10
Completion
2008-03-15
First posted
2017-06-09
Last updated
2017-06-09

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03182712. Inclusion in this directory is not an endorsement.