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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
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%.
Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS.
Mexico City, Mexico
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.
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.
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.
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.
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.
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.
Inflammation Biomarkers (IL-1)
Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
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Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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