Muscular Dystrophy, Duchenne
Conditions
Keywords
Muscular Dystrophy, Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Omega 3, Eicosapentaenoic fatty acid, Docosahexaenoic fatty acid
Brief summary
The purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well as the process of muscular regeneration and the metabolic disorders like obesity and insulin resistance in patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (DMB) compared to those receiving placebo.
Detailed description
DMD and DMB are X-linked diseases caused by mutations in the DMD gene, these mutations have important functional and structural consequences in skeletal muscle. In muscle fiber is observed inflammation and necrosis as a result of lost regenerative capacity. The muscle fibers can be replaced by connective and adipose tissue. In a previous study the investigators identified that 50% of Duchenne and Becker patients in the range of thirteen years old have obesity. In addition, these patients (N=66) have hyperinsulinemia (53.7%) and insulin resistance (48.5%). It is well known that obesity, hyperinsulinemia and insulin resistance have a inflammatory background. It has been demonstrated that eicosapentaenoic fatty acid (EPA) and docosahexaenoic fatty acid (DHA) exhibit anti-inflammatory properties and have beneficial effects on obesity, hyperinsulinemia and insulin resistance in children and adolescents. Objective: Determine the effect of EPA and DHA on inflammation, obesity and insulin resistance in patients with DMD/DMB compared to those receiving placebo.
Interventions
DIETARY_SUPPLEMENTEPA and DHA
Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
DIETARY_SUPPLEMENTPlacebo Comparator
Placebo capsules will contain gelatin and sunflower oil. Fatty acid composition is as follows: lauric (C12:0), 0.19%; myristic (C14:0), 0.29%; palmitic (C16:0), 7.59%; palmitoleic (C16:1), 0.25%; stearic (C18:0), 3.49%; oleic (C18:1), 31.08%; linolenic (C18:3), 1.13%; linoleic (C18:2), 55.64%; DHA 0.02%; arachidic (C20:0), 0.30% and arachidonic (C20:4), 0.01%.
Sponsors
Instituto Nacional de Rehabilitacion
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent and assent by the patient and both parents or guardian. * Patients with clinical diagnosis of Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (DMB) * Patients were not under treatment with corticosteroids
Exclusion criteria
* Patients decided to withdraw from the study * Consumption of dietary supplements containing polyunsaturated fatty acids omega 3. * With hypersensitivity to fish oil. * Patients with respiratory and gastrointestinal problems. Medical responsible assessment the presence of respiratory and gastrointestinal problems. * Patients with difficulty swallowing food, including those who have the difficulty ingesting oil capsules. * Gastrostomy fed patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition (Body Fat) | At baseline and at months 3 and 6 of supplementation. | We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA). |
| Lean Mass | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. | We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA). |
| Anthropometric Measurement: Body Mass Index | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. | We measured weight, height by anthropometric to calculate the body mass index (body mass index). |
| Glucose in Serum | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. | A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method. |
| Insulin in Blood | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. | A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation Biomarker (TNF-A Expression) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR) |
| Inflammation Biomarker (IL-1 Expression) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR). |
| Markers of Muscle Degeneration (Creatinine Kinase) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L. |
| Markers of Muscle Degeneration (MMP9) | Time Frame: At baseline and at months 1, 2, 3 of supplementation. | Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL. |
| Markers of Muscle Degeneration (sFas) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Inflammation Biomarkers (TNF-A) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Markers of Muscle Regeneration (VEGF) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA). |
| Markers of Muscle Regeneration (FGF) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Incorporation of DHA in the Erythrocytes | Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. | The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography. |
| Incorporation of EPA in the Erythrocytes | Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6 | The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography. |
| Markers of Muscle Degeneration (Receptor of Fas) | At baseline and at months 1, 2, 3 and 6 of supplementation. | The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Inflammation Biomarkers (IL-1) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Inflammation Biomarkers (IL-6) | Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation. | Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Inflammation Biomarkers (IL-10) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. |
| Inflammation Biomarker (IL-6 Expression) | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. | The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR). |
Countries
Mexico
Participant flow
Recruitment details
In this study were enrolled DMD/DMB patients from four Hospitals from Mexico city.
Participants by arm
| Arm | Count |
|---|---|
| EPA and DHA Patients received 2.9 g of EPA and DHA per day in 10 capsules (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U | 17 |
| Sunflower Oil Patients received capsules of placebo sunflower fatty at doses of 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The placebo capsules contain each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg | 19 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Sunflower Oil | EPA and DHA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 17 Participants | 36 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.6 years STANDARD_DEVIATION 2.9 | 7.3 years STANDARD_DEVIATION 3.1 | 8.1 years STANDARD_DEVIATION 2.9 |
| Region of Enrollment Mexico | 19 participants | 17 participants | 36 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 1 / 18 | 0 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
Primary
Anthropometric Measurement: Body Mass Index
We measured weight, height by anthropometric to calculate the body mass index (body mass index).
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Month 2 after supplement | 49.6 g/m^2 |
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Month 4 after supplement | 49.9 g/m^2 |
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Month 1 after supplement | 48.2 g/m^2 |
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Month 5 after supplement | 47.4 g/m^2 |
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Month 3 after supplement | 47.4 g/m^2 |
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Month 6 after supplement | 51.7 g/m^2 |
| EPA and DHA | Anthropometric Measurement: Body Mass Index | Basal | 42.5 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Month 6 after supplement | 73.6 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Basal | 72.7 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Month 1 after supplement | 78.3 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Month 2 after supplement | 83.2 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Month 3 after supplement | 82.2 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Month 4 after supplement | 73.7 g/m^2 |
| Sunflower Oil | Anthropometric Measurement: Body Mass Index | Month 5 after supplement | 75.3 g/m^2 |
p-value: >0.05Wilcoxon (Mann-Whitney)
Primary
Body Composition (Body Fat)
We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).
Time frame: At baseline and at months 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Body Composition (Body Fat) | Basal | 172.1 g/Kg of body weight |
| EPA and DHA | Body Composition (Body Fat) | Month 3 after supplement | 180.2 g/Kg of body weight |
| EPA and DHA | Body Composition (Body Fat) | Month 6 after supplement | 181.9 g/Kg of body weight |
| Sunflower Oil | Body Composition (Body Fat) | Basal | 232.7 g/Kg of body weight |
| Sunflower Oil | Body Composition (Body Fat) | Month 3 after supplement | 274.8 g/Kg of body weight |
| Sunflower Oil | Body Composition (Body Fat) | Month 6 after supplement | 298.2 g/Kg of body weight |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Glucose in Serum
A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Glucose in Serum | Month 2 after supplement | 87.5 mg/dL |
| EPA and DHA | Glucose in Serum | Month 4 after supplement | 83.0 mg/dL |
| EPA and DHA | Glucose in Serum | Month 1 after supplement | 84.5 mg/dL |
| EPA and DHA | Glucose in Serum | Month 5 after supplement | 84.0 mg/dL |
| EPA and DHA | Glucose in Serum | Month 3 after supplement | 84.0 mg/dL |
| EPA and DHA | Glucose in Serum | Month 6 after supplement | 82.0 mg/dL |
| EPA and DHA | Glucose in Serum | Basal | 83.5 mg/dL |
| Sunflower Oil | Glucose in Serum | Month 6 after supplement | 88.0 mg/dL |
| Sunflower Oil | Glucose in Serum | Basal | 89.0 mg/dL |
| Sunflower Oil | Glucose in Serum | Month 1 after supplement | 90.0 mg/dL |
| Sunflower Oil | Glucose in Serum | Month 2 after supplement | 89.0 mg/dL |
| Sunflower Oil | Glucose in Serum | Month 3 after supplement | 86.8 mg/dL |
| Sunflower Oil | Glucose in Serum | Month 4 after supplement | 87.0 mg/dL |
| Sunflower Oil | Glucose in Serum | Month 5 after supplement | 89.8 mg/dL |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Insulin in Blood
A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Insulin in Blood | Month 2 after supplement | 12.2 µU/mL |
| EPA and DHA | Insulin in Blood | Month 4 after supplement | 9.2 µU/mL |
| EPA and DHA | Insulin in Blood | Month 1 after supplement | 11.2 µU/mL |
| EPA and DHA | Insulin in Blood | Month 5 after supplement | 8.9 µU/mL |
| EPA and DHA | Insulin in Blood | Month 3 after supplement | 11.4 µU/mL |
| EPA and DHA | Insulin in Blood | Month 6 after supplement | 10.6 µU/mL |
| EPA and DHA | Insulin in Blood | Basal | 10.2 µU/mL |
| Sunflower Oil | Insulin in Blood | Month 6 after supplement | 18.8 µU/mL |
| Sunflower Oil | Insulin in Blood | Basal | 20.9 µU/mL |
| Sunflower Oil | Insulin in Blood | Month 1 after supplement | 17.8 µU/mL |
| Sunflower Oil | Insulin in Blood | Month 2 after supplement | 18.5 µU/mL |
| Sunflower Oil | Insulin in Blood | Month 3 after supplement | 18.0 µU/mL |
| Sunflower Oil | Insulin in Blood | Month 4 after supplement | 21.0 µU/mL |
| Sunflower Oil | Insulin in Blood | Month 5 after supplement | 17.7 µU/mL |
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Lean Mass
We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| EPA and DHA | Lean Mass | Month 5 after supplement | 768.6 g/kg of body weight |
| EPA and DHA | Lean Mass | Month 6 after supplement | 766.7 g/kg of body weight |
| EPA and DHA | Lean Mass | Basal | 774.7 g/kg of body weight |
| EPA and DHA | Lean Mass | Month 1 after supplement | 769.6 g/kg of body weight |
| EPA and DHA | Lean Mass | Month 2 after supplement | 772.4 g/kg of body weight |
| EPA and DHA | Lean Mass | Month 3 after supplement | 757.7 g/kg of body weight |
| EPA and DHA | Lean Mass | Month 4 after supplement | 755.7 g/kg of body weight |
| Sunflower Oil | Lean Mass | Month 5 after supplement | 617.7 g/kg of body weight |
| Sunflower Oil | Lean Mass | Month 2 after supplement | 630.6 g/kg of body weight |
| Sunflower Oil | Lean Mass | Month 6 after supplement | 606.2 g/kg of body weight |
| Sunflower Oil | Lean Mass | Month 4 after supplement | 605.7 g/kg of body weight |
| Sunflower Oil | Lean Mass | Basal | 662.4 g/kg of body weight |
| Sunflower Oil | Lean Mass | Month 3 after supplement | 627.7 g/kg of body weight |
| Sunflower Oil | Lean Mass | Month 1 after supplement | 647.7 g/kg of body weight |
p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Incorporation of DHA in the Erythrocytes
The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.
Time frame: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Incorporation of DHA in the Erythrocytes | Month 1 after supplement | 57.8 percentage of change respect at basal |
| EPA and DHA | Incorporation of DHA in the Erythrocytes | Month 2 after supplement | 31.1 percentage of change respect at basal |
| EPA and DHA | Incorporation of DHA in the Erythrocytes | Month 3 after supplement | 153.4 percentage of change respect at basal |
| EPA and DHA | Incorporation of DHA in the Erythrocytes | Month 4 after supplement | 247.6 percentage of change respect at basal |
| EPA and DHA | Incorporation of DHA in the Erythrocytes | Month 5 after supplement | 116.6 percentage of change respect at basal |
| EPA and DHA | Incorporation of DHA in the Erythrocytes | Month 6 after supplement | 289.4 percentage of change respect at basal |
| Sunflower Oil | Incorporation of DHA in the Erythrocytes | Month 5 after supplement | -0.6 percentage of change respect at basal |
| Sunflower Oil | Incorporation of DHA in the Erythrocytes | Month 1 after supplement | 0.9 percentage of change respect at basal |
| Sunflower Oil | Incorporation of DHA in the Erythrocytes | Month 4 after supplement | 5.6 percentage of change respect at basal |
| Sunflower Oil | Incorporation of DHA in the Erythrocytes | Month 2 after supplement | -2.1 percentage of change respect at basal |
| Sunflower Oil | Incorporation of DHA in the Erythrocytes | Month 6 after supplement | -1.5 percentage of change respect at basal |
| Sunflower Oil | Incorporation of DHA in the Erythrocytes | Month 3 after supplement | -17.4 percentage of change respect at basal |
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
Incorporation of EPA in the Erythrocytes
The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.
Time frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Incorporation of EPA in the Erythrocytes | Month 1 after supplement | 233.0 percentage of change respect at basal |
| EPA and DHA | Incorporation of EPA in the Erythrocytes | Month 2 after supplement | 300.4 percentage of change respect at basal |
| EPA and DHA | Incorporation of EPA in the Erythrocytes | Month 3 after supplement | 552.6 percentage of change respect at basal |
| EPA and DHA | Incorporation of EPA in the Erythrocytes | Month 4 after supplement | 552.7 percentage of change respect at basal |
| EPA and DHA | Incorporation of EPA in the Erythrocytes | Month 5 after supplement | 480.6 percentage of change respect at basal |
| EPA and DHA | Incorporation of EPA in the Erythrocytes | Month 6 after supplement | 446.4 percentage of change respect at basal |
| Sunflower Oil | Incorporation of EPA in the Erythrocytes | Month 5 after supplement | -5.4 percentage of change respect at basal |
| Sunflower Oil | Incorporation of EPA in the Erythrocytes | Month 1 after supplement | -11.8 percentage of change respect at basal |
| Sunflower Oil | Incorporation of EPA in the Erythrocytes | Month 4 after supplement | -20.9 percentage of change respect at basal |
| Sunflower Oil | Incorporation of EPA in the Erythrocytes | Month 2 after supplement | -11.5 percentage of change respect at basal |
| Sunflower Oil | Incorporation of EPA in the Erythrocytes | Month 6 after supplement | -53.1 percentage of change respect at basal |
| Sunflower Oil | Incorporation of EPA in the Erythrocytes | Month 3 after supplement | -19.5 percentage of change respect at basal |
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
Inflammation Biomarker (IL-1 Expression)
The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarker (IL-1 Expression) | Month 1 after supplement | 0.93 percentage of change respect at basal | Standard Deviation 1.24 |
| EPA and DHA | Inflammation Biomarker (IL-1 Expression) | Month 3 after supplement | 0.29 percentage of change respect at basal | Standard Deviation 0.16 |
| EPA and DHA | Inflammation Biomarker (IL-1 Expression) | Month 2 after supplement | 0.69 percentage of change respect at basal | Standard Deviation 0.51 |
| EPA and DHA | Inflammation Biomarker (IL-1 Expression) | Month 6 after supplement | 0.47 percentage of change respect at basal | Standard Deviation 0.4 |
| EPA and DHA | Inflammation Biomarker (IL-1 Expression) | Basal | 1.22 percentage of change respect at basal | Standard Deviation 0.96 |
| Sunflower Oil | Inflammation Biomarker (IL-1 Expression) | Month 6 after supplement | 1.93 percentage of change respect at basal | Standard Deviation 0.87 |
| Sunflower Oil | Inflammation Biomarker (IL-1 Expression) | Basal | 1.7 percentage of change respect at basal | Standard Deviation 1.78 |
| Sunflower Oil | Inflammation Biomarker (IL-1 Expression) | Month 1 after supplement | 1.08 percentage of change respect at basal | Standard Deviation 1.02 |
| Sunflower Oil | Inflammation Biomarker (IL-1 Expression) | Month 2 after supplement | 0.86 percentage of change respect at basal | Standard Deviation 0.41 |
| Sunflower Oil | Inflammation Biomarker (IL-1 Expression) | Month 3 after supplement | 0.66 percentage of change respect at basal | Standard Deviation 0.46 |
p-value: 0.05t-test, 1 sided
Secondary
Inflammation Biomarker (IL-6 Expression)
The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarker (IL-6 Expression) | Month 1 after supplement | 1.26 percentage of change respect at basal | Standard Deviation 1.95 |
| EPA and DHA | Inflammation Biomarker (IL-6 Expression) | Month 3 after supplement | 0.6 percentage of change respect at basal | Standard Deviation 0.26 |
| EPA and DHA | Inflammation Biomarker (IL-6 Expression) | Month 2 after supplement | 1.7 percentage of change respect at basal | Standard Deviation 0.88 |
| EPA and DHA | Inflammation Biomarker (IL-6 Expression) | Month 6 after supplement | 0.77 percentage of change respect at basal | Standard Deviation 0.39 |
| EPA and DHA | Inflammation Biomarker (IL-6 Expression) | Basal | 2.27 percentage of change respect at basal | Standard Deviation 2.7 |
| Sunflower Oil | Inflammation Biomarker (IL-6 Expression) | Month 6 after supplement | 9.5 percentage of change respect at basal | Standard Deviation 1.17 |
| Sunflower Oil | Inflammation Biomarker (IL-6 Expression) | Basal | 2.45 percentage of change respect at basal | Standard Deviation 2.45 |
| Sunflower Oil | Inflammation Biomarker (IL-6 Expression) | Month 1 after supplement | 5.33 percentage of change respect at basal | Standard Deviation 4.47 |
| Sunflower Oil | Inflammation Biomarker (IL-6 Expression) | Month 2 after supplement | 7.82 percentage of change respect at basal | Standard Deviation 4.44 |
| Sunflower Oil | Inflammation Biomarker (IL-6 Expression) | Month 3 after supplement | 3.5 percentage of change respect at basal | Standard Deviation 2.72 |
p-value: <0.05t-test, 1 sided
Secondary
Inflammation Biomarkers (IL-1)
Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarkers (IL-1) | Month 1 after supplement | 2.05 percentage of change respect at basal | Standard Deviation 53.77 |
| EPA and DHA | Inflammation Biomarkers (IL-1) | Month 2 after supplement | -6.00 percentage of change respect at basal | Standard Deviation 60.69 |
| EPA and DHA | Inflammation Biomarkers (IL-1) | Month 3 after supplement | -43.84 percentage of change respect at basal | Standard Deviation 34.96 |
| EPA and DHA | Inflammation Biomarkers (IL-1) | Month 6 after supplement | -57.04 percentage of change respect at basal | Standard Deviation 31.56 |
| Sunflower Oil | Inflammation Biomarkers (IL-1) | Month 6 after supplement | -10.97 percentage of change respect at basal | Standard Deviation 70.95 |
| Sunflower Oil | Inflammation Biomarkers (IL-1) | Month 1 after supplement | 21.74 percentage of change respect at basal | Standard Deviation 60.76 |
| Sunflower Oil | Inflammation Biomarkers (IL-1) | Month 3 after supplement | -9.89 percentage of change respect at basal | Standard Deviation 63.68 |
| Sunflower Oil | Inflammation Biomarkers (IL-1) | Month 2 after supplement | -2.49 percentage of change respect at basal | Standard Deviation 76.14 |
p-value: <0.05Kruskal-Wallis
Secondary
Inflammation Biomarkers (IL-10)
Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarkers (IL-10) | Month 1 after supplement | 27.66 percentage of change respect at basal | Standard Deviation 115.8 |
| EPA and DHA | Inflammation Biomarkers (IL-10) | Month 2 after supplement | 4.83 percentage of change respect at basal | Standard Deviation 114.65 |
| EPA and DHA | Inflammation Biomarkers (IL-10) | Month 6 after supplement | 108.85 percentage of change respect at basal | Standard Deviation 173.87 |
| EPA and DHA | Inflammation Biomarkers (IL-10) | Month 3 after supplement | 46.49 percentage of change respect at basal | Standard Deviation 171.49 |
| Sunflower Oil | Inflammation Biomarkers (IL-10) | Month 3 after supplement | -39.91 percentage of change respect at basal | Standard Deviation 32.72 |
| Sunflower Oil | Inflammation Biomarkers (IL-10) | Month 1 after supplement | -8.89 percentage of change respect at basal | Standard Deviation 68.42 |
| Sunflower Oil | Inflammation Biomarkers (IL-10) | Month 6 after supplement | -41.21 percentage of change respect at basal | Standard Deviation 52.6 |
| Sunflower Oil | Inflammation Biomarkers (IL-10) | Month 2 after supplement | -21.16 percentage of change respect at basal | Standard Deviation 50.03 |
p-value: <0.05Kruskal-Wallis
Secondary
Inflammation Biomarkers (IL-6)
Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarkers (IL-6) | Month 1 after supplement | 0.60 percentage of change respect at basal | Standard Deviation 43.8 |
| EPA and DHA | Inflammation Biomarkers (IL-6) | Month 2 after supplement | -10.57 percentage of change respect at basal | Standard Deviation 44.95 |
| EPA and DHA | Inflammation Biomarkers (IL-6) | Month 3 after supplement | -29.33 percentage of change respect at basal | Standard Deviation 35.17 |
| EPA and DHA | Inflammation Biomarkers (IL-6) | Month 6 after supplement | -52.33 percentage of change respect at basal | Standard Deviation 20.89 |
| Sunflower Oil | Inflammation Biomarkers (IL-6) | Month 6 after supplement | -24.83 percentage of change respect at basal | Standard Deviation 48.15 |
| Sunflower Oil | Inflammation Biomarkers (IL-6) | Month 1 after supplement | 0.08 percentage of change respect at basal | Standard Deviation 63.76 |
| Sunflower Oil | Inflammation Biomarkers (IL-6) | Month 3 after supplement | -16.61 percentage of change respect at basal | Standard Deviation 46.39 |
| Sunflower Oil | Inflammation Biomarkers (IL-6) | Month 2 after supplement | -3.6 percentage of change respect at basal | Standard Deviation 41.66 |
p-value: <0.05Kruskal-Wallis
Secondary
Inflammation Biomarkers (TNF-A)
Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarkers (TNF-A) | Month 1 after supplement | 8.77 percentage of change respect at basal | Standard Deviation 50.01 |
| EPA and DHA | Inflammation Biomarkers (TNF-A) | Month 2 after supplement | -22.04 percentage of change respect at basal | Standard Deviation 28.04 |
| EPA and DHA | Inflammation Biomarkers (TNF-A) | Month 3 after supplement | -43.79 percentage of change respect at basal | Standard Deviation 32.69 |
| EPA and DHA | Inflammation Biomarkers (TNF-A) | Month 6 after supplement | -65.78 percentage of change respect at basal | Standard Deviation 26.62 |
| Sunflower Oil | Inflammation Biomarkers (TNF-A) | Month 6 after supplement | -60.56 percentage of change respect at basal | Standard Deviation 18.77 |
| Sunflower Oil | Inflammation Biomarkers (TNF-A) | Month 1 after supplement | -1.45 percentage of change respect at basal | Standard Deviation 37.47 |
| Sunflower Oil | Inflammation Biomarkers (TNF-A) | Month 3 after supplement | -37.76 percentage of change respect at basal | Standard Deviation 29.69 |
| Sunflower Oil | Inflammation Biomarkers (TNF-A) | Month 2 after supplement | -21.01 percentage of change respect at basal | Standard Deviation 37.69 |
p-value: >0.05Kruskal-Wallis
Secondary
Inflammation Biomarker (TNF-A Expression)
The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Inflammation Biomarker (TNF-A Expression) | Month 1 after supplement | 2.07 percentage of change respect at basal | Standard Deviation 2.6 |
| EPA and DHA | Inflammation Biomarker (TNF-A Expression) | Month 3 after supplement | 1.05 percentage of change respect at basal | Standard Deviation 2 |
| EPA and DHA | Inflammation Biomarker (TNF-A Expression) | Month 2 after supplement | 1.3 percentage of change respect at basal | Standard Deviation 2.07 |
| EPA and DHA | Inflammation Biomarker (TNF-A Expression) | Month 6 after supplement | 1.25 percentage of change respect at basal | Standard Deviation 1.43 |
| EPA and DHA | Inflammation Biomarker (TNF-A Expression) | Basal | 1.82 percentage of change respect at basal | Standard Deviation 2.6 |
| Sunflower Oil | Inflammation Biomarker (TNF-A Expression) | Month 6 after supplement | 0.52 percentage of change respect at basal | Standard Deviation 0.41 |
| Sunflower Oil | Inflammation Biomarker (TNF-A Expression) | Basal | 1.15 percentage of change respect at basal | Standard Deviation 0.63 |
| Sunflower Oil | Inflammation Biomarker (TNF-A Expression) | Month 1 after supplement | 1.05 percentage of change respect at basal | Standard Deviation 0.94 |
| Sunflower Oil | Inflammation Biomarker (TNF-A Expression) | Month 2 after supplement | 2.12 percentage of change respect at basal | Standard Deviation 0.93 |
| Sunflower Oil | Inflammation Biomarker (TNF-A Expression) | Month 3 after supplement | 2.27 percentage of change respect at basal | Standard Deviation 3.11 |
p-value: <0.05t-test, 1 sided
Secondary
Markers of Muscle Degeneration (Creatinine Kinase)
The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EPA and DHA | Markers of Muscle Degeneration (Creatinine Kinase) | Month 1 after supplement | 23.30 percentage of change respect at basal | Standard Deviation 38.56 |
| EPA and DHA | Markers of Muscle Degeneration (Creatinine Kinase) | Month 2 after supplement | 30.10 percentage of change respect at basal | Standard Deviation 58.23 |
| EPA and DHA | Markers of Muscle Degeneration (Creatinine Kinase) | Month 3 after supplement | 8.45 percentage of change respect at basal | Standard Deviation 38.24 |
| EPA and DHA | Markers of Muscle Degeneration (Creatinine Kinase) | Month 6 after supplement | 4.46 percentage of change respect at basal | Standard Deviation 42.67 |
| Sunflower Oil | Markers of Muscle Degeneration (Creatinine Kinase) | Month 6 after supplement | -1.52 percentage of change respect at basal | Standard Deviation 33.98 |
| Sunflower Oil | Markers of Muscle Degeneration (Creatinine Kinase) | Month 1 after supplement | 8.82 percentage of change respect at basal | Standard Deviation 52.59 |
| Sunflower Oil | Markers of Muscle Degeneration (Creatinine Kinase) | Month 3 after supplement | 0.75 percentage of change respect at basal | Standard Deviation 44.76 |
| Sunflower Oil | Markers of Muscle Degeneration (Creatinine Kinase) | Month 2 after supplement | -9.95 percentage of change respect at basal | Standard Deviation 55.82 |
p-value: >0.05Kruskal-Wallis
Secondary
Markers of Muscle Degeneration (MMP9)
Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Markers of Muscle Degeneration (MMP9) | Month 1 after supplement | -31.5 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (MMP9) | Month 2 after supplement | -3.5 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (MMP9) | Month 3 after supplement | -21.2 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (MMP9) | Month 6 after supplement | -23.6 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (MMP9) | Month 6 after supplement | 39.9 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (MMP9) | Month 1 after supplement | -13.0 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (MMP9) | Month 3 after supplement | 53.5 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (MMP9) | Month 2 after supplement | 47.7 percentage of change respect at basal |
p-value: >0.05Kruskal-Wallis
Secondary
Markers of Muscle Degeneration (Receptor of Fas)
The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Markers of Muscle Degeneration (Receptor of Fas) | Month 1 after supplement | 16.5 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (Receptor of Fas) | Month 2 after supplement | 2.4 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (Receptor of Fas) | Month 3 after supplement | -15.7 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (Receptor of Fas) | Month 6 after supplement | -16.5 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (Receptor of Fas) | Month 6 after supplement | -30.0 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (Receptor of Fas) | Month 1 after supplement | -2.0 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (Receptor of Fas) | Month 3 after supplement | -16.3 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (Receptor of Fas) | Month 2 after supplement | -10.1 percentage of change respect at basal |
p-value: >0.05Kruskal-Wallis
Secondary
Markers of Muscle Degeneration (sFas)
The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Markers of Muscle Degeneration (sFas) | Month 1 after supplement | 11.1 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (sFas) | Month 2 after supplement | 14.2 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (sFas) | Month 3 after supplement | 7.2 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Degeneration (sFas) | Month 6 after supplement | 18.3 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (sFas) | Month 6 after supplement | 20.7 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (sFas) | Month 1 after supplement | 15.8 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (sFas) | Month 3 after supplement | 14.5 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Degeneration (sFas) | Month 2 after supplement | 15.8 percentage of change respect at basal |
p-value: >0.05Kruskal-Wallis
Secondary
Markers of Muscle Regeneration (FGF)
Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Markers of Muscle Regeneration (FGF) | Month 1 after supplement | -13.6 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Regeneration (FGF) | Month 2 after supplement | 2.4 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Regeneration (FGF) | Month 3 after supplement | -0.92 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Regeneration (FGF) | Month 6 after supplement | -28.0 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (FGF) | Month 6 after supplement | -70.9 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (FGF) | Month 1 after supplement | -37.3 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (FGF) | Month 3 after supplement | -57.1 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (FGF) | Month 2 after supplement | -9.5 percentage of change respect at basal |
p-value: 0.05Kruskal-Wallis
Secondary
Markers of Muscle Regeneration (VEGF)
Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EPA and DHA | Markers of Muscle Regeneration (VEGF) | Month 1 after supplement | -25.9 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Regeneration (VEGF) | Month 2 after supplement | 2.4 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Regeneration (VEGF) | Month 3 after supplement | -15.7 percentage of change respect at basal |
| EPA and DHA | Markers of Muscle Regeneration (VEGF) | Month 6 after supplement | -15.9 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (VEGF) | Month 6 after supplement | 14.3 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (VEGF) | Month 1 after supplement | -5.7 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (VEGF) | Month 3 after supplement | -16.3 percentage of change respect at basal |
| Sunflower Oil | Markers of Muscle Regeneration (VEGF) | Month 2 after supplement | -9.5 percentage of change respect at basal |
p-value: >0.05Kruskal-Wallis