Type2 Diabetes MellitusNCT03182712
n-3 Fatty Acid Effects in T2DM After Acute High Intensity Exercise
A study testing n-3 PUFA Group in people with Type2 Diabetes Mellitus, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- n-3 PUFA Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to 15 Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes
- Male and female
- Age between 40 and 60 years old.
- Must be able to do exercise
Who cannot join
- Smoking;
- Clinical diagnosis of kidney, pulmonary or heart diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Porto Alegre
Pôrto Alegre, Rio Grande do Sul, 90035-903
About this study
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
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).
Read the 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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- n-3 PUFA Group, Placebo Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFA GroupDietary 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.
Placebo GroupDietary supplement
Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: n-3 PUFA Group |
| Placebo Group | Placebo comparator | Subjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks. Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on hs-CRP (High-sensitivity C reactive protein)
Marker of inflammation expressed in mg/dL
Measured: Measured before the supplementation (baseline) and after eight weeks of supplementation
Secondary outcomes (3)
Changes on F2-isoprostanes
Marker of oxidative stress expressed in ng/mL
Measured: Measured before the supplementation (baseline) and after eight weeks of supplementation
Changes on thiobarbituric acid reactivity
Marker of oxidative stress expressed in nmol/mL
Measured: Measured before the supplementation (baseline) and after eight weeks of supplementation
Changes on Total Antioxidant activity
Marker of oxidative stress expressed in contains per minute
Measured: Measured before the supplementation (baseline) and after eight weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startFeb 2007
- Primary completion10 Feb 2008
- Study completion15 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurício Krause, Federal University of Rio Grande do Sul
- Investigators
- Rogério Friedman, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182712
- Sponsor's protocol ID
- HCPA 06-222
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data, including body composition, inflammatory and oxidative stress markers and metabolites.
Publications
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.
PubMed 29713249
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03182712
- Acronym / sponsor ID
- HCPA 06-222
- Conditions
- Type2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- 10 Feb 2008 (actual)
- Study completion
- 15 Mar 2008 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA Group | Experimental | Dietary Supplement: n-3 PUFA GroupSubjects 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. |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo GroupSubjects receiving gelatin capsules (500mg). Three capsules were ingested daily for eight weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Type 2 Diabetes
- Male and female
- Age between 40 and 60 years old.
- Must be able to do exercise
Key exclusion criteria (2 listed)
- Smoking;
- Clinical diagnosis of kidney, pulmonary or heart diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 PUFA GroupParticipants 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. | Dietary supplement | n-3 PUFA Group |
| Placebo GroupParticipants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner. | Dietary supplement | Placebo Group |
Primary outcome
Changes on hs-CRP (High-sensitivity C reactive protein)
Time frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Marker of inflammation expressed in mg/dL
3 secondary outcomes
Changes on F2-isoprostanes
Time frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Changes on thiobarbituric acid reactivity
Time frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Changes on Total Antioxidant activity
Time frame: Measured before the supplementation (baseline) and after eight weeks of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Derived from this study: PubMed 29713249Fayh 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.
- Individual participant dataSharing planned: Yes. All data, including body composition, inflammatory and oxidative stress markers and metabolites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogério Friedman, PhD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 PUFA Group in people with Type2 Diabetes Mellitus, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on hs-CRP (High-sensitivity C reactive protein) (time frame: Measured before the supplementation (baseline) and after eight weeks of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.