MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
Phase: NA
Conditions: X-Linked Dystonia Parkinsonism
Sponsor: Sunshine Care Foundation

 
 
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COVER PAGE 
 
Date/Version:  January 25, 2017 / 3.0 
 
Title of Protocol: 
The effect of MINGO (rice, mongo, moringa) as a nutritional supplement in patients 
with X-Linked Dystonia Parkinsonism (XDP) in Capiz, Philippines 
Protocol Number: 
NCT03019458 
Principal Investigator: Criscely Go, M.D.  
Co-Investigators: 
None 
Study Staff: 
MDSP members in the Philippines; Other healthcare providers and office staff, 
Sunshine Care Foundation staff and community advocates (CAs) 
_____________________________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Background and Significance 
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 well-
being. 
 
Specific Aims 
1. To determine the effect of the addition of MINGO on the following: 
a. Patient body mass index (BMI) 
b. Patient mid-upper arm circumference (MUAC) 
2. Ensure that the addition of MINGO to diets of patients with XDP does not cause significant 
disturbance of baseline metabolic parameters, such as:  
a. Uric acid 
b. BUN 
c. Creatinine 
d. Potassium 
e. A1C (tested in diabetic patients) 
 
Research studies under this protocol will be conducted through: 
 
Subject recruitment and enrollment at: 
o The Health Centrum Hospital in Banica Roxas City 
o Local trips around the island of Panay and surrounding islands 
 
Subject Selection 
We will enroll any individual who meets the following eligibility criteria: 
Inclusion: 
 
Patient is above the age of 18 years old 
 
Patients is diagnosed with XDP or a related movement disorder that often coexists with XDP by a 
neurologist with movement disorders training 
 
Patient has a “yes” response to the criteria “supportive home environment” in the patient’s most 
recent “Doctor’s monthly report”  
 
Patient meets the following accessibility criteria as determined by discussions with clinical staff:  
a. Accessibility to the patient’s home based on proximity from the research staff and 
availability of proper roads and public transportation 
 
Exclusion: 
 
Patients who have movement abnormalities that have prevented the clinical staff to obtain an 
accurate height and weight measurement such as bed ridden or wheel chair bound patients 
 
Patients who have metabolic derangements prior to the study (i.e. creatinine twice the normal, A1C 
greater than 7) and confirmed by physician’s medical opinion 

 
 
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 
Patients who are taking pharmacological agents and medicinal supplements (i.e. agents other than 
what is considered to be part of the patient’s standard care as determined by MDSP clinicians at the 
MDSP XDP clinic) that may affect weight  
 
Patients that report other medical conditions that can affect BMI such as hypo-, hyper-thyroidism, or 
history of malignancy 
 
Patients who have recently been hospitalized within the last 2 weeks from the start of the trial 
 
Patients who have a G-tube or NGT 
 
Withdrawal Criteria: 
 
Subjects can stop a study visit or study procedure at any time 
 
Subjects can ask to have their data removed from analysis at any time 
 
The principal investigator can withdraw a subject during a study visit or procedure at any time for 
safety or noncompliance. 
 
Source of subjects and recruitment methods 
The study will use a convenience sample.  Subjects are recruited through two sources. 
1. The XDP Clinic and Registry at The Health Centrum Hospital in Banica Roxas City 
2. Patient home visits by Sunshine Care Foundation employees 
 
Remuneration 
Subjects receive no remuneration for joining the study. 
 
Subject Enrollment 
There is no set limit to the number of individuals who can participate in the trial. The specific target 
population that the study will target is XDP patients who get care at the Health Centrum.  The number will be 
determined by how many patients meet the inclusion/exclusion criteria. 
 
Subject Prescreening 
Subject prescreening consists of reviewing the medical records of patients with XDP seen at the Movement 
Disorders clinic in The Health Centrum in Roxas City. The researchers will identify patients who meet the 
eligibility criteria. Additionally, discussions with clinical staff will aid the researchers in determining 
whether the patient meets the accessibility criteria, such as the accessibility to the patient’s home based on 
proximity from the research staff and availability of proper roads and public transportation. Eligible patients 
will be identified, contacted, and asked whether they are interested in participating in the study. An 
identifying prescreening log will be kept for all individuals screened.   
 
Procedures for obtaining informed consent 
Written consent is obtained from all subjects: 
 
If the potential subject is unable to give consent due to physical condition, consent is obtained from the 
parents/legal guardian or spouse/next-of-kin. 
 
For subjects physically incapable of signing the consent form due to their disease:  These subjects retain the 
ability to understand the concepts of the study and to evaluate the risk and benefit of being in the study when 
it is explained verbally, and the individual is able to indicate approval or disapproval to study enrollment. 
The consent form will document the method used to communicate with the prospective subject and the 
specific means by which the prospective subject communicated agreement to participate in the study. An 
impartial third party will witness the entire consent process and sign the consent document. 
 
In all cases, a copy signed by both the subject and study staff is placed in the subject’s research file. 
 
Enrollment of people within vulnerable groups 

 
 
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People with XDP have, at present, an incurable disease that often causes significant movement abnormalities 
such that men with XDP are prevented from returning to work.  Thus, men with XDP typically use social 
assistance given their unemployment.  Medical care through the XDP Clinic is provided free-of-charge 
(through the support of the Sunshine Foundation) to people diagnosed with XDP by a neurologist with 
movement disorder training.  Verbally, and in the written consent form, we will clearly state that people with 
XDP can decline research participation and still receive medical care through the XDP Clinic.  Medical care 
for people with XDP is NOT contingent on participation in research. 
 
Study Procedures 
 
a. Assessing Baseline Metabolic Parameters 
Once informed consent has been obtained, enrolled patients will be tested for the following metabolic 
parameters: uric acid, BUN, creatinine, potassium, and, exclusively for diabetic patients, A1C. These tests 
will require at most 5mL of blood from patients. These values will be collected before the three-month 
period of MINGO consumption by the trial group to satisfy the lab value exclusion criteria. 
 
b. Patient Randomization 
Placement into the trial or control group will be randomly assigned. The trial group will receive and consume 
MINGO throughout the duration of the study while the control group will not. Both groups will undergo the 
same number of study visits, with the same data information collected.  
 
c. Trial Group MINGO Consumption: Training and Requirements 
The researchers will organize a training session before beginning the trial where study staff, namely the 
community advocates (CAs), will be trained on the correct preparation of MINGO, how many sachets are 
required of patients, how to prepare food logs, and how and when measurements will be taken. The study 
staff will then teach the patients and caregivers belonging to the trial group this information in their homes.  
 
MINGO sachets can be consumed mixed with other food and liquid items and will be not be used to replace 
regular meals. Caregivers will ensure intake of MINGO by the patient and study staff will collect the empty 
sachet bags every two weeks, as well as review food logs to ensure that MINGO is being consumed properly. 
Any report of non-compliance will be logged and participants will be withdrawn from the study once they 
are found to have missed more than six MINGO sachets per week.  
 
d. Patient Data Collection Procedures 
Each CA will be assigned a number of patients enrolled in the study. They will measure the weight of their 
group of patients for the entire duration of the study using a calibrated weight scale. The scale will be 
calibrated before every use (i.e. every two weeks). Each CA throughout the duration of the study will use the 
same scale. The CA will take weight measurements every two weeks at patient homes and a total of seven 
measurements will be done in three months.  
 
Study staff will measure MUAC at the start of the study. MUAC measurements will be taken before the 
study, every four weeks, and at the end of the study.  
 
At the end of the trial, the researchers may do multiple chart reviews in order to gather information on the 
patient’s disease severity, caregiving, and family information.   
 
Study Visits and Parameters to be Measured 
Information that may be collected from/about subjects is listed on the: 
 
Data Collection Sheets 
o GUID information sheet: 10 identifying data elements for generating a Global Unique 
Identifier (GUID) 
o Movement disorder rating scales results from patient medical records 
 
Burke-Fahn-Marsden Dystonia Scale (BFMDS) 

 
 
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 
Unified Parkinson’s Disease Rating Scale (UPDRS) 
 
XDP-MDSP Rating Scale 
o Swallowing assessments from patient medical records 
 
MGH-SST 
 
EAT-10 
o Caregiving scale and family information from patient medical records 
 
Family APGAR 
 
Modified Caregiver Strain Index (MCSI) 
 
WHO-5 Index of Well being (WHO-5) 
o Trial participant sheet 
 
Weight 
 
Weight history 
 
MUAC 
 
Metabolic lab results 
o Demographic information from patient medical records 
 
Patient education 
 
Average annual income 
 
Food logs from caregivers and patients 
 
Procedures 
Phlebotomy 
5 mL of blood from vein puncture may be used to obtain metabolic parameters on all subjects. The blood 
will be drawn by a professional trained in phlebotomy and will not be handled or collected by any of the 
study staff. A local lab that provides blood analysis for clinical use will be consulted.  
 
Data Processing and Storage 
Clinical data sheets will be labeled with the subject’s full name. At data entry, clinical data sheets will be 
checked for accuracy and completion. The subject’s Global Unique Identifier (GUID) will be generated. The 
GUID will be recorded on a code key corresponding to the subject’s name. No one at NeuroBANK™ will 
ever have access to the code key. 
 
The subject’s GUID and non-identifying information collected on data sheets will be manually entered into 
NeuroBANK™.  NeuroBANK™ is a collaboration and data repository platform maintained by the 
Massachusetts General Hospital (MGH) Neurological Clinical Research Institute (NCRI).  This platform 
facilitates: 
1. Capture of clinical and research data from neurologic patients for individual projects in a structured 
and secure system; 
2. Aggregating and sharing uniform, de-identified and/or anonymized datasets for secondary analyses. 
 
Follow-up information, including research genetic screening will be added to NeuroBANK™. 
 
Data and Sample Distribution 
Data is stored through NeuroBANKTM.  Requests for use of coded data are submitted to NeuroBANKTM 
staff.  The requests are reviewed based on the quality of the research performed by the requesting-researcher 
to determine if the request should be fulfilled. NeuroBANKTM receive identifying subject information, so 
none is distributed. 
 
If a subject wishes to withdraw from the research, he/she can do so by making the request to the study 
investigators.  We will destroy the source documents and delete the associated electronic files.  We will 
contact the NeuroBANKTM. 
 

 
 
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Risks and Discomforts 
Consumption of MINGO may have adverse health effects on patients that have not been previously observed 
in MINGO consumers. This is the first trial involving the consumption of MINGO in adult consumers. All 
previous studies have been conducted on young children.  
 
For patients with difficulties eating, consuming more food may present further strain and effort for the 
patient and family. Particularly for patients with severe swallowing difficulties, there is a risk of choking and 
aspirating whenever these patients consume food products. The MINGO study is not adding to this present 
risk, as the patients will continue to eat food and drink liquids in their daily lives.  
 
Venipuncture (blood collection) is a standard procedure in medical practice and carries negligible risks.  
There is slight transient discomfort at the puncture site as the needle is inserted.  Slight bleeding that is easily 
controlled by temporary pressure and bruising at the needle site are potential discomforts.  Rarely, people 
faint after a blood draw.  If a subject experiences lightheadedness, he/she will be asked to lie down, rest and 
have a small snack until the feeling subsides. 
 
Potential Benefits 
For Subjects 
Subjects in the trial group who consume MINGO may increase their BMI and MUAC. These increases may 
help the subjects obtain an ideal weight for their caloric needs and help them in their overall health status. 
After the study is finished and the results from the study are disseminated, subjects may purchase MINGO or 
receive it for free from charity organizations if efficacy is established.  
 
For Society 
If MINGO is proven effective in increasing BMI and MUAC in the research subjects, doctors may encourage 
the consumption of MINGO in all patients with XDP. Furthermore, the consumption of MINGO may be 
tested on and/or given to other patient populations with similar difficulties to patients with XDP such as 
severe weight loss, dysphagia, and high caloric expenditure. 
 
Monitoring and Quality Assurance 
Privacy and Confidentiality 
Original identifying study documents are stored in a limited access building in a locked file cabinet in the 
local dystonia clinic at The Health Centrum. Only study staff will have access to the filing cabinet key. Data 
input will only be conducted in the dystonia clinic.  
 
The NeuroBANK™ software and subjects’ data reside on servers located in the Partners Healthcare Systems 
(Partners) server farm.  Physical and software access to the servers and security is provided by the Partners 
IT department.  Members of the NeuroBANK™ management team will do everything, within reason, to keep 
a participant’s identity protected.  Each NeuroBANK™ user will have a unique user name and password to 
help audit database access. 
 
Although under federal law the patient’s health information is private, the following parties may be given 
access: the Health Centrum ethics board that oversees the research; people from organizations that provide 
independent accreditation and oversight of hospitals and research; people or groups that we hire to do work 
for us, such as data storage companies, insures, and lawyers, federal and state agencies; and public health and 
safety authorities. 
 
Safety and Outcomes Monitoring 
All subjects will have contact information for the principal investigator if they have questions at any time.  
Dr. Criscely Go is responsible for the overall management of the study and will maintain regular 
communication with all of the study staff.  
 

 
 
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If a study participant is injured during the course of the study, appropriate measures will be implemented. 
Members of the study staff will meet as a team, investigate the details of the injury further, inform the IRB, 
and notify the current medical team, including the patient’s general practitioner and medical staff at the XDP 
Movement Disorders clinic in Roxas City. The staff may not offer the patient the care needed to treat any 
injury that directly results from taking part in this research study. The staff will encourage the patient to bill 
the insurance company or other third parties, if appropriate, for the care they may get for the injury. There 
are no plans to pay the patient or give the patient other compensation for an injury, should one occur. 
 
 
 
Publishing Rights: 
The following individuals will have the authorship right to publish the results of the study for the direct or 
indirect role in seeing this project through:  Criscely L Go, Jan Kristopher De Guzman, Jed Noel Ong, Mark 
Angelo Ang, Patrick Acuna, Greta Solinap, Nutan Sharma, Abegail Aguil, and Gilbert Distura (if he is still 
with us for the duration of the study).  We will also give an acknowledgement to the Health Centrum and the 
Sunshine Care Foundation for the support that was given. 
 
Addendum to MINGO protocol: 
 
For the control patients that will receive MINGO as part of their participation in the MINGO trial, we will 
ask them if they would like to participate in MINGO extension.  In the extension, we will ask them if they 
are willing to take MINGO 6 times a day and undergo measurements similar to the original experimental 
group.  That is, a writing a weekly food log, bimonthly weight measurements, and monthly Mid Upper Arm 
Circumference.