MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

Study Overview
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Brief Summary
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To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.

Detailed Description
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X-linked dystonia parkinsonism (XDP, formerly known as DYT3) occurs primarily in Filipino males and is characterized by neurodegenerative dystonia and parkinsonism. It is currently recognized to have wide phenotypic variability relating to age of onset, location of disease onset and rate of severity/disease progression. Most patients begin with focal dystonia that generalizes with the development of parkinsonism later in disease course. XDP patients suffer from severe nutritional loss due to symptoms such as dysphagia, loss of appetite, and consistently high metabolic requirements brought about by their movement disorder. Approximately 79% of patients with XDP have experienced rapid weight loss since the onset of their disease. It is the aim of the researchers to assess the clinical usefulness of adding a nutritional supplement to the daily dietary needs of these patients. MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. Mingo has gained popularity as an emergency food in disaster relief operations due to the ease of its preparation, its high nutritional value and relatively low price. For the last two years, it has also been used as an agent for nutritional build up in malnourished populations of children. This study will provide valuable information on whether patients with XDP can increase their weight by consuming MINGO, which will lead to improvements in the patients' medical care and wellbeing.

Official Title
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MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial

Conditions
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X-Linked Dystonia Parkinsonism

Intervention / Treatment
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* Dietary Supplement: MINGO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is above the age of 18 Positive Diagnosis of XDP by movement disorder specialist/fellow Subject with a yes response to a supportive home environment in the patient's most recent doctors monthly report Subject are easily accessible to passable roads and pubic transportation Exclusion Criteria: Subjects who have extreme movements that prevent staff from performing BMI or MUAC measurements Subjects who have abnormal metabolic labs prior to the start of the study Subjects who are taking pharmacological or medicinal supplements that may effect weight Subjects who have been hospitalized within the last 2 weeks from the start of the trial Subjects who have a Nasogastric tube or G-tube Subjects with a history of other diseases that my effect weight (eg: hypo/hyperthyroidism)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MINGO<br>MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary | Dietary Supplement: MINGO<br>* 6 20oz sachets will be taken daily by intervention group<br>|
| No Intervention: Control<br>The control group is required to eat their normal diet. They are also required to keep a daily food diary. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. | The investigators will first take a baseline Body Mass Index in kg/m^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period. | after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality | number of deaths in both arms at the end of the study | 3 months (study close out) | 
| Number of Hospitalizations Secondary to Infectious Causes | number of hospitalizations secondary to infections in both arms at the end of the study | 3 months (study close out) | 
| Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure | It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI | After baseline measurements, the investigators will measure the MUAC evey month for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective randomized trial