An interventional study of MINGO in X-Linked Dystonia Parkinsonism, sponsored by Sunshine Care Foundation. Completed at 1 site in Philippines. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by Sunshine Care Foundation · Not applicable, Interventional, and Supportive care
To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.
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.
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's enrollment of 50 is above the median of 32 across 181 interventional studies indexed under Dystonia.
Browse Dystonia studies →This is the only study on the registry with Sunshine Care Foundation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The control group is required to eat their normal diet. They are also required to keep a daily food diary.
6 20oz sachets will be taken daily by intervention group
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.
Time frame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
All Cause Mortality
number of deaths in both arms at the end of the study
Time frame: 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
Time frame: 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
Time frame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months
| Milestone | MINGO | Control |
|---|---|---|
| Started | 24 | 26 |
| Completed | 24 | 25 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
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.
| Kg/m^2 | MINGO | Control |
|---|---|---|
| baseline | 18.86 (17.66 to 20.06) | 18.17 (17.24 to 19.09) |
| week 2 | 19.00 (17.75 to 20.24) | 18.31 (17.30 to 19.31) |
| week 4 | 19.14 (17.91 to 20.37) | 18.27 (17.25 to 19.29) |
| week 6 | 19.11 (17.90 to 20.33) | 18.06 (17.01 to 19.11) |
| week 8 | 19.15 (17.89 to 20.40) | 18.24 (17.24 to 19.24) |
| week 10 | 19.03 (17.77 to 20.28) | 18.05 (17.01 to 19.10) |
| week 12 | 19.07 (17.83 to 20.31) | 17.95 (16.90 to 18.99) |
number of deaths in both arms at the end of the study
| Participants | MINGO | Control |
|---|---|---|
| All Cause Mortality | 0 | 1 |
number of hospitalizations secondary to infections in both arms at the end of the study
| Participants | MINGO | Control |
|---|---|---|
| Number of Hospitalizations Secondary to Infectious Causes | 0 | 0 |
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
| cm | MINGO | Control |
|---|---|---|
| baseline | 26.54 (25.39 to 27.59) | 26.54 (25.24 to 27.84) |
| month 1 | 26.93 (25.86 to 28.00) | 26.58 (25.23 to 27.93) |
| month 2 | 26.96 (25.85 to 28.07) | 26.69 (25.13 to 28.07) |
| month 3 | 26.69 (25.41 to 27.97) | 26.62 (25.03 to 28.18) |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MINGO | 0/24 (0%) | 0/24 (0%) | 4/24 (16.7%) |
| Control | 1/26 (3.8%) | 0/26 (0%) | 1/26 (3.8%) |
| Event | MINGO | Control |
|---|---|---|
| Intolerance to taking MINGOGastrointestinal disorders | 4/24 | 0/26 |
| GI symptomsGastrointestinal disorders | 0/24 | 1/26 |
| Age, Continuous(years) | MINGO | Control | Total |
|---|---|---|---|
| Mean | 54.2 ± 1.6 | 56.4 ± 1.6 | 55.4 ± 1.2 |
| Sex: Female, Male(Participants) | MINGO | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 24 | 26 | 50 |
| Race (NIH/OMB)(Participants) | MINGO | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 24 | 26 | 50 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | MINGO | Control | Total |
|---|---|---|---|
| Philippines | 24 | 26 | 50 |
| Duration of Illness(years) | MINGO | Control | Total |
|---|---|---|---|
| Mean | 9.4 ± 1.1 | 8.2 ± 1.1 | 8.8 ± 0.8 |
| Body Mass Index (BMI)(kg/m^2) | MINGO | Control | Total |
|---|---|---|---|
| Mean | 18.9 ± 0.6 | 18.2 ± 0.4 | 18.5 ± 0.4 |
| Mean Upper Arm Circumference (MUAC)(cm) | MINGO | Control | Total |
|---|---|---|---|
| Mean | 26.5 ± 0.5 | 26.5 ± 0.6 | 26.5 ± 0.4 |
| Burkes-Fahn-Marsden (BFM)(units on a scale) | MINGO | Control | Total |
|---|---|---|---|
| Mean | 44.1 ± 5.3 | 40.2 ± 4.8 | 42.1 ± 3.5 |
2 further baseline measures are reported on the registry.
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