MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

Sunshine Care Foundation

Status: Completed

Conditions: X-Linked Dystonia Parkinsonism

Treatments: Dietary Supplement: MINGO

Study type: Interventional

Funder types: Other

Identifiers

NCT03019458

MINGO-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MINGO

Experimental group

Description:

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

Treatment:

Dietary Supplement: MINGO

Control

No Intervention group

Description:

The control group is required to eat their normal diet. They are also required to keep a daily food diary.