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DINAMITE Study Nutritional State and Effect Diet in Mitochondrial Disease (DINAMITE)

Primary Purpose

Mitochondrial Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diet intervention
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitochondrial Disorders focused on measuring malnutrition, diet intervention, Nutritional Assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Proven mitochondrial m.3243A>G mutation
  • Age > 18 years
  • No medical contra indication for receiving Nutritional Assessment after overnight fasting
  • Informed consent

Exclusion Criteria:

  • Overnight fasting is contraindicated for medical reasons, for example due to high risk for hypoglycemia.
  • Pacemaker
  • Claustrophobia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    control group

    intervention group

    Arm Description

    Usual care followed bij diet intervention after 6 months

    diet intervention

    Outcomes

    Primary Outcome Measures

    Nutritional Status
    Patient Generated- Subjective Global Assessment (Pg-SGA)

    Secondary Outcome Measures

    Activity
    measured with sensewear in Kcal
    body composition
    measured with bioimpedance analysis (FFMI)
    waist circumference
    (cm)
    upper arm circumference
    (cm)
    antropometric
    BMI
    food intake
    measured by 3 day eating report
    occurrence of gastrointestinal problems
    questionaire
    hand grip strength
    Kg
    fatigue
    measured with the CIS (Checklist Individual tension) fatigue
    quality of life
    Short Form (SF)-36

    Full Information

    First Posted
    October 31, 2014
    Last Updated
    April 13, 2017
    Sponsor
    Radboud University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02286856
    Brief Title
    DINAMITE Study Nutritional State and Effect Diet in Mitochondrial Disease
    Acronym
    DINAMITE
    Official Title
    DINAMITE Study: An Explorative Study of the Effect of Dietary Intervention on Body Function and Quality of Life in Adults With Mitochondrial Disease Caused by the m.3243A>G Mutation.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The m.3243A>G mutation is the most frequent cause of mitochondrial disease in adults, for which currently no therapy is available and treatment is solely supportive. Since both malnutrition and obesity are frequently seen in these patients, an adequate nutritional intervention to improve body composition and function might improve the quality of life of these patients. Hypothesis / research questions Hypothesis part 1: Patients with mitochondrial disorders caused by the m.3243 A>G mutation have an increased risk for malnutrition. Hypothesis part 2 : Intervention study: Dietary intervention in adults with a mitochondrial disorder caused by the m.3243 A>G mutation has a positive effect on nutritional status, activity, hand grip strength, body composition, food intake, fatigue and quality of life.
    Detailed Description
    Background The Nijmegen Centre for Metabolic Disease (NCMD) harbors a unique research center with much experience in the characterization of the group of patients with the m3243A>G mutation. For a mitochondrial disease no therapy is available. Treatment is supportive, and aims at improving the quality of life. Clinical findings in patients with mitochondrial diseases may both comprise malnutrition and obesity. While a nutritional intervention might constitute a symptomatic treatment for these patients, there are very few data in adults to guide such a strategy. Malnutrition is defined as a state of nutrition in which a deficiency, excess (or imbalance) of energy, protein, and other nutrients causes measurable adverse effects on body composition and function, and clinical outcome. In patients with mitochondrial disease there is by definition malnutrition on a cellular level due to disturbed metabolism with energy deficit. A logical next step is to study the effect of this energy shortage on complaints in the adult population by describing characteristics of this patient group in relation to the nutritional status. In the same vein, a controlled dietary intervention might result in an evidence based dietary therapy. Frequent symptoms of patients with OXPHOS disorders include e gastrointestinal problems, fatigue and dysphagia. We suspect that these symptoms increase the risk for malnutrition. Research in patients with neuromuscular disorders have demonstrated that none of the patients had an adequate nutritional state, with a a lowered Fat Free Mass and a high fat percentage. Study design: Part 1 comprises a comprehensive Nutritional Assessment (NA) including indirect calorimetry (IC), bioimpedance analysis (BIA), anthropometry, eating report, activity measurement using the actometer, and completion of questionnaires including the Cis-fatigue and SF-36 for Quality of life. In Part 2 a 2-armed randomized controlled intervention study is performed . One group starts with a dietary intervention whereas the second group (controls) starts with a non-interventional period of 6 months. After this period the dietary intervention is also performed in the second group . The dietary intervention implies optimizing the diet based on individually calculated energy and protein requirements, while for remaining nutrients advise in line with recommended daily amounts (RDA) will be provided. Extended Nutritional Assessment measurements will be repeated every 3 months. Indirect Calorimetry will be performed at the start of the study. Objective of the study: To increase our knowledge about the nutritional status of adult patients with mitochondrial disease and its determinants. Evaluate effects of a dietary intervention in these patients on nutritional status and body functions (muscle strength, activity, fatigue) and quality of life. To develop criteria to refer patients with mitochondrial disease for dietary intervention. DINAMITE study acronym DIner: Hot meal, super NA: Nutritional Assessment or Nutrition + Adults MIT MITochondrial disorder E Energy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mitochondrial Disorders
    Keywords
    malnutrition, diet intervention, Nutritional Assessment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    Usual care followed bij diet intervention after 6 months
    Arm Title
    intervention group
    Arm Type
    Active Comparator
    Arm Description
    diet intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet intervention
    Intervention Description
    The dietary intervention implies optimizing the diet based on individually calculated energy and protein requirements, while for remaining nutrients advise in line with recommended daily amounts (RDA) will be provided. This nutrients will be translated to food products and lifestyle advice is added. Individual diet counseling will be part of the intervention to improve compliance.
    Primary Outcome Measure Information:
    Title
    Nutritional Status
    Description
    Patient Generated- Subjective Global Assessment (Pg-SGA)
    Time Frame
    3- 6 months
    Secondary Outcome Measure Information:
    Title
    Activity
    Description
    measured with sensewear in Kcal
    Time Frame
    3-6 months
    Title
    body composition
    Description
    measured with bioimpedance analysis (FFMI)
    Time Frame
    3- 6 months
    Title
    waist circumference
    Description
    (cm)
    Time Frame
    3- 6 months
    Title
    upper arm circumference
    Description
    (cm)
    Time Frame
    3- 6 months
    Title
    antropometric
    Description
    BMI
    Time Frame
    3- 6 months
    Title
    food intake
    Description
    measured by 3 day eating report
    Time Frame
    3- 6 months
    Title
    occurrence of gastrointestinal problems
    Description
    questionaire
    Time Frame
    3- 6 months
    Title
    hand grip strength
    Description
    Kg
    Time Frame
    3- 6 months
    Title
    fatigue
    Description
    measured with the CIS (Checklist Individual tension) fatigue
    Time Frame
    3- 6 months
    Title
    quality of life
    Description
    Short Form (SF)-36
    Time Frame
    3- 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Proven mitochondrial m.3243A>G mutation Age > 18 years No medical contra indication for receiving Nutritional Assessment after overnight fasting Informed consent Exclusion Criteria: Overnight fasting is contraindicated for medical reasons, for example due to high risk for hypoglycemia. Pacemaker Claustrophobia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen, dr
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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