DINAMITE Study Nutritional State and Effect Diet in Mitochondrial Disease

NCT02286856 | Completed

• 1 other identifier: NL39724.091.1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitochondrial Disorders

Keywords

malnutrition, diet intervention, Nutritional Assessment

Outcome Measures

Primary Outcomes (1)

• Nutritional Status

  Patient Generated- Subjective Global Assessment (Pg-SGA)

  3- 6 months

Secondary Outcomes (10)

• Activity

  3-6 months

• body composition

  3- 6 months

• waist circumference

  3- 6 months

• upper arm circumference

  3- 6 months

• antropometric

  3- 6 months

Study Arms (2)

control group

OTHER

Usual care followed bij diet intervention after 6 months

Behavioral: diet intervention

intervention group

ACTIVE COMPARATOR

diet intervention

Behavioral: diet intervention

Interventions

diet intervention BEHAVIORAL

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.

control group; intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Mitochondrial Diseases; Malnutrition

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Study Officials

• Janssen, dr

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 10, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2016-04