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

F

Federal University of Rio Grande do Sul

Status

Completed

Conditions

Type2 Diabetes Mellitus

Treatments

Dietary Supplement: n-3 PUFA Group
Dietary Supplement: Placebo Group

Study type

Interventional

Funder types

Other

Identifiers

NCT03182712
HCPA 06-222

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups, including a placebo group

n-3 PUFA Group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: n-3 PUFA Group
Placebo Group
Placebo Comparator group
Description:
Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks.
Treatment:
Dietary Supplement: Placebo Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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