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

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

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

Study Overview

• Status: Completed
• Conditions: X-Linked Dystonia Parkinsonism
• Intervention / Treatment: Dietary supplement: MINGO

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Capiz
    • Roxas City, Capiz, Philippines, 5800
      • Health Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunshine Care Foundation
• Collaborators: Massachusetts General Hospital; Jose R. Reyes Memorial Medical Center
• Investigators: Principal Investigator: Criscely L Go, MD,FPNA,DPBP, Jose R. Reyes Memorial Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2017
• Primary Completion (ACTUAL): May 8, 2017
• Study Completion (ACTUAL): June 26, 2017

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (ESTIMATE): January 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: prospective randomized trial
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Parkinsonian Disorders; Genetic Diseases, X-Linked
• Other Study ID Numbers: MINGO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No