Clinical trial NCT03182712: n-3 Fatty Acid Effects in T2DM After Acute High Intensity Exercise
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes on hs-CRP (High-sensitivity C reactive protein)
timeFrame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Secondary outcomes:
measure: Changes on F2-isoprostanes
timeFrame: Measured before the supplementation (baseline) and after eight weeks of supplementation
measure: Changes on thiobarbituric acid reactivity
timeFrame: Measured before the supplementation (baseline) and after eight weeks of supplementation
measure: Changes on Total Antioxidant activity
timeFrame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Other outcomes:
Locations:
city: Pôrto Alegre
country: Brazil
facility: Clinical Hospital of Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Rogério Friedman, PhD
role: STUDY_DIRECTOR
References:
citation: Fayh APT, Borges K, Cunha GS, Krause M, Rocha R, de Bittencourt PIH Jr, Moreira JCF, Friedman R, da Silva Rossato J, Fernandes JR, Reischak-Oliveira A. Effects of n-3 fatty acids and exercise on oxidative stress parameters in type 2 diabetic: a randomized clinical trial. J Int Soc Sports Nutr. 2018 Apr 23;15:18. doi: 10.1186/s12970-018-0222-2. eCollection 2018.