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Completed

NCT Number: NCT03182712

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

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).

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Key information

Conditions

Type2 Diabetes Mellitus

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital of Porto Alegre

Pôrto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 PUFA Group

Dietary Supplement

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 Group

Dietary Supplement

Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 9, 2017
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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