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
About this trial
This is an interventional treatment trial for Mitochondrial Disorders focused on measuring malnutrition, diet intervention, Nutritional Assessment
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
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
NCT ID
NCT02286856
First Posted
October 31, 2014
Last Updated
April 13, 2017
Sponsor
Radboud University Medical Center
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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DINAMITE Study Nutritional State and Effect Diet in Mitochondrial Disease
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