Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients

February 8, 2018 updated by: Maricela Rodriguez Cruz, Coordinación de Investigación en Salud, Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 06720
        • Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Dietary supplement: EPA and DHA
Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
Other Names:
  • omega 3 fatty acid
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.
Dietary supplement: Placebo 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition (Body Fat)
Time Frame: 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).
At baseline and at months 3 and 6 of supplementation.
Lean Mass
Time Frame: 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).
At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Anthropometric Measurement: Body Mass Index
Time Frame: 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).
At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Glucose in Serum
Time Frame: 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.
At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Insulin in Blood
Time Frame: 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).
At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation Biomarkers (TNF-A)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarkers (IL-1)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarkers (IL-6)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.
Inflammation Biomarkers (IL-10)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (IL-6 Expression)
Time Frame: 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).
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (TNF-A Expression)
Time Frame: 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)
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (IL-1 Expression)
Time Frame: 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).
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (Creatinine Kinase)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (MMP9)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 of supplementation.
Markers of Muscle Degeneration (sFas)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (Receptor of Fas)
Time Frame: 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.
At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Regeneration (VEGF)
Time Frame: 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).
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Regeneration (FGF)
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Incorporation of DHA in the Erythrocytes
Time Frame: 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.
Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Incorporation of EPA in the Erythrocytes
Time Frame: 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.
Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

Instituto Nacional de Rehabilitacion

Investigators

  • Principal Investigator: Maricela Rodriguez-Cruz, PhD, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (ESTIMATE)

April 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHA/EPA in Dunchenne
  • 180058 (CONACYT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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