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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: n-3 PUFA Group
* Dietary Supplement: Placebo Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The selected subjects were referred to the University laboratory. During their first visit, the subjects were submitted to perform the first high intensity sub-maximal test. In the same day, volunteers received the supplementation capsules that should be taken throughout eight weeks, as described in the supplementation section. The subjects were randomly assigned to two groups: (1) group placebo and (2) n-3 PUFA group. After the supplementation period, all subjects reported back to hospital to biochemical testing and thereafter to the university exercise laboratory for the second high intensity sub-maximal test, following the same protocol described above.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-3 PUFA Group<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo Group<br>Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks. | Dietary Supplement: Placebo Group<br>* Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on hs-CRP (High-sensitivity C reactive protein) | 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 | Marker of oxidative stress expressed in ng/mL | Measured before the supplementation (baseline) and after eight weeks of supplementation | 
| Changes on thiobarbituric acid reactivity | Marker of oxidative stress expressed in nmol/mL | Measured before the supplementation (baseline) and after eight weeks of supplementation | 
| Changes on Total Antioxidant activity | Marker of oxidative stress expressed in contains per minute | Measured before the supplementation (baseline) and after eight weeks of supplementation |