Effect of Eicosapentaenoic Fatty Acid (EPA) and Docosahexaenoic Fatty Acids (DHA) Supplementation on the Inflammation State and Metabolic Disorders in Patients With Duchenne Muscular Dystrophy or Becker Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Body Composition (Body Fat)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients decided to withdraw from the study
- •Consumption of dietary supplements containing polyunsaturated fatty acids omega
- •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.
研究组 & 干预措施
EPA and DHA
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.
干预措施: EPA and DHA (Dietary Supplement)
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.
干预措施: Placebo Comparator (Dietary Supplement)
结局指标
主要结局
Body Composition (Body Fat)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Inflammation Biomarkers (TNF-A)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Inflammation Biomarkers (IL-1)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Inflammation Biomarkers (IL-6)(Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.)
- Inflammation Biomarkers (IL-10)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Inflammation Biomarker (IL-6 Expression)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Inflammation Biomarker (TNF-A Expression)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Inflammation Biomarker (IL-1 Expression)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Markers of Muscle Degeneration (Creatinine Kinase)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Markers of Muscle Degeneration (MMP9)(Time Frame: At baseline and at months 1, 2, 3 of supplementation.)
- Markers of Muscle Degeneration (sFas)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Markers of Muscle Degeneration (Receptor of Fas)(At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Markers of Muscle Regeneration (VEGF)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Markers of Muscle Regeneration (FGF)(Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.)
- Incorporation of DHA in the Erythrocytes(Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.)
- Incorporation of EPA in the Erythrocytes(Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6)
研究者
Maricela Rodriguez Cruz
PhD
Coordinación de Investigación en Salud, Mexico