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

NCT03182712 | Completed

• 1 other identifier: HCPA 06-222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes on F2-isoprostanes

  Measured before the supplementation (baseline) and after eight weeks of supplementation

• Changes on thiobarbituric acid reactivity

  Measured before the supplementation (baseline) and after eight weeks of supplementation

• Changes on Total Antioxidant activity

  Measured before the supplementation (baseline) and after eight weeks of supplementation

Study Arms (2)

n-3 PUFA Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks.

Dietary Supplement: Placebo Group

Interventions

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.

n-3 PUFA Group

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.

Placebo Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of Type 2 Diabetes
• Male and female
• Age between 40 and 60 years old.
• Must be able to do exercise

You may not qualify if:

• Smoking;
• Clinical diagnosis of kidney, pulmonary or heart diseases

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Clinical Hospital of Porto Alegre

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

Location

Related Publications (1)

• 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.

  PMID: 29713249 DERIVED

Study Officials

• Rogério Friedman, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 9, 2017
• Study Start: February 1, 2007
• Primary Completion: February 10, 2008
• Study Completion: March 15, 2008
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)