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| ID | Type | Description | Link |
|---|---|---|---|
| 180058 | Other Grant/Funding Number | CONACYT |
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| Name | Class |
|---|---|
| Instituto Nacional de Rehabilitacion | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA and DHA | Experimental | Supplementation of 2.7 g/d of EPA and DHA were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes were specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade. |
|
| Placebo Comparator | Placebo Comparator | Supplementation of placebo with sunflower fatty at doses of 2.7 g/d were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil, so, it did not present anti-inflammatory or insulin sensitivity effects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA and DHA | Dietary Supplement | Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition (Body Fat) | We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA). | 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). | 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). | 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. | 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). | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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: At baseline and at months 1, 2, 3 and 6 of supplementation. |
| Inflammation Biomarkers (IL-1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maricela Rodriguez-Cruz, PhD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS. | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22701119 | Background | Cruz Guzman Odel R, Chavez Garcia AL, Rodriguez-Cruz M. Muscular dystrophies at different ages: metabolic and endocrine alterations. Int J Endocrinol. 2012;2012:485376. doi: 10.1155/2012/485376. Epub 2012 Jun 3. | |
| 26089900 | Background | Rodriguez-Cruz M, Sanchez R, Escobar RE, Cruz-Guzman Odel R, Lopez-Alarcon M, Bernabe Garcia M, Coral-Vazquez R, Matute G, Velazquez Wong AC. Evidence of Insulin Resistance and Other Metabolic Alterations in Boys with Duchenne or Becker Muscular Dystrophy. Int J Endocrinol. 2015;2015:867273. doi: 10.1155/2015/867273. Epub 2015 May 19. |
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In this study were enrolled DMD/DMB patients from four Hospitals from Mexico city.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sunflower Oil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Composition (Body Fat) | We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA). | Posted | Median | Full Range | g/Kg of body weight | At baseline and at months 3 and 6 of supplementation. |
|
One patient presented vomiting and diarrhea, the patient had three evacuations during the night in a period of 3 hours and vomiting occurred for a period of 10 minutes. These complications occurred only once in the first month of supplementation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPA and DHA | Supplementation of 2.9 g / d of EPA and DHA will be provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade. EPA and DHA: Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting and diarrhea | Gastrointestinal disorders | Gastrointestinal | Non-systematic Assessment | One patient presented vomiting and diarrhea, the patient had three evacuations and one time of vomiting. |
Limitations:
The sample size was not completed mainly because patients were not eligible for inclusion.
It was not possible to standardize the technical procedures for DNA fragmentation evaluation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maricela Rodriguez-Cruz | IMSS | 5256276900 | . 22483 | maricela.rodriguez.cruz@gmail.com |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo Comparator | Dietary Supplement | 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%. |
|
Plasma cytokine IL-1 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. |
| 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: 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: 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: 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: 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: 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: 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: 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: 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. | 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: 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: 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: 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: At baseline, at 1, 2, 3, 4, 5, and 6 |
| 28987470 | Result | Rodriguez-Cruz M, Cruz-Guzman ODR, Almeida-Becerril T, Solis-Serna AD, Atilano-Miguel S, Sanchez-Gonzalez JR, Barbosa-Cortes L, Ruiz-Cruz ED, Huicochea JC, Cardenas-Conejo A, Escobar-Cedillo RE, Yam-Ontiveros CA, Ricardez-Marcial EF. Potential therapeutic impact of omega-3 long chain-polyunsaturated fatty acids on inflammation markers in Duchenne muscular dystrophy: A double-blind, controlled randomized trial. Clin Nutr. 2018 Dec;37(6 Pt A):1840-1851. doi: 10.1016/j.clnu.2017.09.011. Epub 2017 Sep 23. |
| 34779542 | Derived | Villaldama-Soriano MA, Rodriguez-Cruz M, Hernandez-De la Cruz SY, Almeida-Becerril T, Cardenas-Conejo A, Wong-Baeza C. Pro-inflammatory monocytes are increased in Duchenne muscular dystrophy and suppressed with omega-3 fatty acids: A double-blind, randomized, placebo-controlled pilot study. Eur J Neurol. 2022 Mar;29(3):855-864. doi: 10.1111/ene.15184. Epub 2021 Nov 26. |
| 30420291 | Derived | Rodriguez-Cruz M, Atilano-Miguel S, Barbosa-Cortes L, Bernabe-Garcia M, Almeida-Becerril T, Cardenas-Conejo A, Del Rocio Cruz-Guzman O, Maldonado-Hernandez J. Evidence of muscle loss delay and improvement of hyperinsulinemia and insulin resistance in Duchenne muscular dystrophy supplemented with omega-3 fatty acids: A randomized study. Clin Nutr. 2019 Oct;38(5):2087-2097. doi: 10.1016/j.clnu.2018.10.017. Epub 2018 Oct 30. |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Lean Mass | We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA). | Posted | Mean | Full Range | g/kg of body weight | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. |
|
|
|
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| Primary | Anthropometric Measurement: Body Mass Index | We measured weight, height by anthropometric to calculate the body mass index (body mass index). | Posted | Median | Full Range | g/m^2 | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. |
|
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| Primary | Glucose in Serum | A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method. | Posted | Median | Full Range | mg/dL | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. |
|
|
|
|
| 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). | Posted | Median | Full Range | µU/mL | At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. |
|
|
|
|
| Secondary | Inflammation Biomarkers (TNF-A) | Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| Secondary | Inflammation Biomarkers (IL-1) | Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| Secondary | Inflammation Biomarkers (IL-6) | Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation. |
|
|
|
|
| Secondary | Inflammation Biomarkers (IL-10) | Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL. | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| Secondary | Markers of Muscle Degeneration (Creatinine Kinase) | The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L. | Posted | Mean | Standard Deviation | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| 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. | Posted | Median | Full Range | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 of supplementation. |
|
|
|
|
| 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. | Posted | Median | Full Range | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
|
|
|
| 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. | Posted | Median | Full Range | percentage of change respect at basal | At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
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|
| Secondary | Markers of Muscle Regeneration (VEGF) | Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA). | Posted | Median | Full Range | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
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|
|
| 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. | Posted | Median | Full Range | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. |
|
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| Secondary | Incorporation of DHA in the Erythrocytes | The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography. | Posted | Median | Full Range | percentage of change respect at basal | Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. |
|
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|
|
| Secondary | Incorporation of EPA in the Erythrocytes | The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography. | Posted | Median | Full Range | percentage of change respect at basal | Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6 |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Sunflower Oil | Supplementation of placebo with 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 capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil and so will not expected to produce anti-inflammatory or insulin sensitivity effects. Placebo Comparator: Sunflower oil; the placebo capsules will also contain sunflower oil. 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. | 0 | 22 | 0 | 22 | 0 | 22 |
|
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| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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