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Completed

NCT Number: NCT03019458

MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Centrum

Roxas City, Capiz, 5800, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MINGO

Dietary Supplement

6 20oz sachets will be taken daily by intervention group

Primary outcomes

  1. The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.

    Time frame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months

    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.

Secondary outcomes

  1. All Cause Mortality

    Time frame: 3 months (study close out)

    number of deaths in both arms at the end of the study

  2. Number of Hospitalizations Secondary to Infectious Causes

    Time frame: 3 months (study close out)

    number of hospitalizations secondary to infections in both arms at the end of the study

  3. Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure

    Time frame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months

    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

Sponsors and collaborators

Lead sponsor

Sunshine Care Foundation

Other

Collaborators

  • Jose R. Reyes Memorial Medical Center
  • Massachusetts General Hospital

Registry information

Official study title

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

Acronym: MINGO

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.