Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03019458
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborators:
Jose R. Reyes Memorial Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Sunshine Care Foundation

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.


Layout table for study information
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


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.



Primary Outcome Measures :
  1. The change in Body Mass Index (BMI in kg/m2) from baseline using a bathroom weighing scale. [ Time Frame: after baseline BMI, we will measure BMI every 2 weeks for 3 months ]
    The investigators will first take a baseline BMI in kg/m2 for both control and interventional 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 BMI 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. Change in Mid Upper Arm Circumference (MUAC) in cm using a tailor's tape measure from baseline. [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019458


Locations
Layout table for location information
Philippines
Health Centrum
Roxas City, Capiz, Philippines, 5800
Sponsors and Collaborators
Sunshine Care Foundation
Jose R. Reyes Memorial Medical Center
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Criscely L Go, MD,FPNA,DPBP Jose R. Reyes Memorial Medical Center

Layout table for additonal information
Responsible Party: Sunshine Care Foundation
ClinicalTrials.gov Identifier: NCT03019458     History of Changes
Other Study ID Numbers: MINGO-001
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Dystonia
Dystonic Disorders
Parkinsonian Disorders
Dystonia Musculorum Deformans
Genetic Diseases, X-Linked
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn