Mitochondrial Diseases Clinical Trial
— NAMITOOfficial title:
Nutritional Assessment in Patients Affected by Mitochondrial Cytopathy
Verified date | April 2016 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
The aim of this study is to assess nutritional intake (quantitatively and qualitatively), nutritional state and body composition of patients suffering from mitochondrial cytopathy, compared to healthy controls. The energy intake will be calculated through dietary protocols, the energy expenditure by indirect calorimetry and body composition will be performed with bio-impedance analysis. Further on, the investigators expect to be able to provide nutritional counselling to this population in order to increase energy and protein intake, which may improve health and well-being.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a clinical presentation suggestive of mitochondrial cytopathy, in whom mitochondrial deletions above 20% have been found in muscle - =/>18 years - Willing and able to give written informed consent Exclusion Criteria - Patients with poor knowledge of the study languages (German and French) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Arpa J, Cruz-Martínez A, Campos Y, Gutiérrez-Molina M, García-Rio F, Pérez-Conde C, Martín MA, Rubio JC, Del Hoyo P, Arpa-Fernández A, Arenas J. Prevalence and progression of mitochondrial diseases: a study of 50 patients. Muscle Nerve. 2003 Dec;28(6):690-5. — View Citation
El-Hattab AW, Scaglia F. Mitochondrial DNA depletion syndromes: review and updates of genetic basis, manifestations, and therapeutic options. Neurotherapeutics. 2013 Apr;10(2):186-98. doi: 10.1007/s13311-013-0177-6. Review. — View Citation
Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. — View Citation
Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krähenbühl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9. doi: 10.1016/j.clnu.2008.03.012. Epub 2008 May 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Energy and nutrients intake (Measured in kcal) | Measured in kcal (7 days food recall protocol to check for nutrients which aggravate symptoms & to provide nutritional counselling) | At baseline | No |
Secondary | Differences in nutritional risk (Measured in NRS2002) | Measured in NRS2002 score points | At baseline | No |
Secondary | Differences in nutritional status Measured in laboratory parameters (blood and urine) | Measured in laboratory parameters (blood and urine) | At baseline | No |
Secondary | Difference in body composition Measured in bioimpedance analysis BIA and anthropometrics (TSF [mm], MAMC (cm^2), Handgrip test (kg)) | At baseline | No | |
Secondary | Difference in resting energy expenditure Measured in kcal (indirect calorimetry) | Measured in kcal (indirect calorimetry) | At baseline | No |
Secondary | Difference in quality of life Measured in SF36v2 score | Measured in SF36v2 score | At baseline | No |
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