MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients (MINGO)

• ClinicalTrials.gov Identifier: NCT03019458
• Recruitment Status: Completed
• First Posted: January 12, 2017
• Results First Posted: April 6, 2020
• Last Update Posted: April 30, 2020
• Sponsor: Sunshine Care Foundation
• Collaborators: Jose R. Reyes Memorial Medical Center; Massachusetts General Hospital
• Information provided by (Responsible Party): Sunshine Care Foundation

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
X-Linked Dystonia Parkinsonism	Dietary Supplement: MINGO	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
• Actual Study Start Date: February 10, 2017
• Actual Primary Completion Date: May 8, 2017
• Actual Study Completion Date: June 26, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: MINGO; 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; 6 20oz sachets will be taken daily by intervention group
No Intervention: Control; The control group is required to eat their normal diet. They are also required to keep a daily food diary.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Philippines

Health Centrum

Roxas City, Capiz, Philippines, 5800

Sponsors and Collaborators

Sunshine Care Foundation

Jose R. Reyes Memorial Medical Center

Massachusetts General Hospital

Investigators

• Principal Investigator: Criscely L Go, MD,FPNA,DPBP; Jose R. Reyes Memorial Medical Center

  Study Documents (Full-Text)

Documents provided by Sunshine Care Foundation:

Study Protocol  [PDF] January 25, 2017

Statistical Analysis Plan  [PDF] November 11, 2016

More Information

• Responsible Party: Sunshine Care Foundation
• ClinicalTrials.gov Identifier: NCT03019458
• Other Study ID Numbers: MINGO-001
• First Posted: January 12, 2017
• Results First Posted: April 6, 2020
• Last Update Posted: April 30, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sunshine Care Foundation:

prospective randomized trial

Additional relevant MeSH terms:

Dystonia; Dystonic Disorders; Parkinsonian Disorders; Genetic Diseases, X-Linked; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Movement Disorders; Central Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Genetic Diseases, Inborn