n-3 Fatty Acid Effects in T2DM After Acute High Intensity Exercise
Primary Purpose
Type2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
n-3 PUFA Group
Placebo Group
Sponsored by

About this trial
This is an interventional basic science trial for Type2 Diabetes Mellitus
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
Sites / Locations
- Clinical Hospital of Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
n-3 PUFA Group
Placebo Group
Arm 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.
Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks.
Outcomes
Primary Outcome Measures
Changes on hs-CRP (High-sensitivity C reactive protein)
Marker of inflammation expressed in mg/dL
Secondary Outcome Measures
Changes on F2-isoprostanes
Marker of oxidative stress expressed in ng/mL
Changes on thiobarbituric acid reactivity
Marker of oxidative stress expressed in nmol/mL
Changes on Total Antioxidant activity
Marker of oxidative stress expressed in contains per minute
Full Information
NCT ID
NCT03182712
First Posted
June 1, 2017
Last Updated
June 7, 2017
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03182712
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 10, 2008 (Actual)
Study Completion Date
March 15, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
n-3 PUFA Group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 PUFA Group
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Group
Intervention Description
Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.
Primary Outcome Measure Information:
Title
Changes on hs-CRP (High-sensitivity C reactive protein)
Description
Marker of inflammation expressed in mg/dL
Time Frame
Measured before the supplementation (baseline) and after eight weeks of supplementation
Secondary Outcome Measure Information:
Title
Changes on F2-isoprostanes
Description
Marker of oxidative stress expressed in ng/mL
Time Frame
Measured before the supplementation (baseline) and after eight weeks of supplementation
Title
Changes on thiobarbituric acid reactivity
Description
Marker of oxidative stress expressed in nmol/mL
Time Frame
Measured before the supplementation (baseline) and after eight weeks of supplementation
Title
Changes on Total Antioxidant activity
Description
Marker of oxidative stress expressed in contains per minute
Time Frame
Measured before the supplementation (baseline) and after eight weeks of supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogério Friedman, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Hospital of Porto Alegre
City
Pôrto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All data, including body composition, inflammatory and oxidative stress markers and metabolites.
Citations:
PubMed Identifier
29713249
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.
Results Reference
derived
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n-3 Fatty Acid Effects in T2DM After Acute High Intensity Exercise
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