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

Type2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182712
• Other study ID #: HCPA 06-222
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: June 7, 2017
• Start date: February 2007
• Est. completion date: March 15, 2008

Study information

• Verified date: June 2017
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2008
• Est. primary completion date: February 10, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Dietary Supplement:
• n-3 PUFA Group
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
Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Porto Alegre	Pôrto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes on F2-isoprostanes	Marker of oxidative stress expressed in ng/mL	Measured before the supplementation (baseline) and after eight weeks of supplementation
Secondary	Changes on thiobarbituric acid reactivity	Marker of oxidative stress expressed in nmol/mL	Measured before the supplementation (baseline) and after eight weeks of supplementation
Secondary	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