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| Name | Class |
|---|---|
| Jose R. Reyes Memorial Medical Center | OTHER_GOV |
| Massachusetts General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINGO | Experimental | 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 |
|
| Control | No Intervention | The control group is required to eat their normal diet. They are also required to keep a daily food diary. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINGO | Dietary Supplement | 6 20oz sachets will be taken daily by intervention group |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Criscely L Go, MD,FPNA,DPBP | Jose R. Reyes Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Centrum | Roxas City | Capiz | 5800 | Philippines |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 MINGO: 6 20oz sachets will be taken daily by intervention group. There were 24 subjects who were part of the MINGO arm. |
| FG001 | Control | The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 MINGO: 6 20oz sachets will be taken daily by intervention group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We proposed an intention to treat analysis, so regardless of whether an XDP subject took the prescribed # of MINGO packets or not we analyzed everyone who entered the trial | Posted | Mean | 95% Confidence Interval | Kg/m^2 | after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 MINGO: 6 20oz sachets will be taken daily by intervention group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerance to taking MINGO | Gastrointestinal disorders | Non-systematic Assessment | Any intolerance to taking MINGO that caused the subject to stop taking the supplement including 1 due to vomiting, 1 due to the subjective sensation to fullness, and 2 due to the fact they did not like the taste of MINGO. |
A major limitation to this trial is that it was a community-based clinical trial that relied on 14 CHWs to measure the weight and MUAC due to the far distance and difficult terrain. The accuracy of subject's food diary is a limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Acuna | Sunshine Care Foundation | +63 947 959-1851 | patrick_acuna@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2017 | Mar 20, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2016 | Mar 20, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C564048 | Dystonia 3, Torsion, X-Linked |
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| 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 |
| BG001 | Control | The control group is required to eat their normal diet. They are also required to keep a daily food diary. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of Illness | Mean | Standard Deviation | years |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Mean Upper Arm Circumference (MUAC) | Mean | Standard Deviation | cm |
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| Burkes-Fahn-Marsden (BFM) | This is a scale that is done to score dystonia severity from 0 to 120 with higher numbers indicating worse outcome. A movement disorder specialist was the one who performed the scale. | Mean | Standard Deviation | units on a scale |
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| Eating Assessment Tool (EAT-10) | EAT-10 is a subjective swallowing screening tool for dysphagia that ranges from 0-40 with higher scores meaning more difficulty in swallowing | Mean | Standard Deviation | units on a scale |
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| MGH-Swallowing Screening Tool (MGH-SST) | MGH SST is an objective swallowing screening tool to determine the risk of aspiration from 0-5 with 5 being the highest risk to aspiration | Mean | Standard Deviation | units on a scale |
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| OG001 | Control | The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group |
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| Secondary | All Cause Mortality | number of deaths in both arms at the end of the study | Everyone who enrolled were analyzed | Posted | Count of Participants | Participants | 3 months (study close out) |
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| Secondary | Number of Hospitalizations Secondary to Infectious Causes | number of hospitalizations secondary to infections in both arms at the end of the study | all participants were analyzed | Posted | Count of Participants | Participants | 3 months (study close out) |
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| Secondary | 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 | All participants in the trial | Posted | Mean | 95% Confidence Interval | cm | After baseline measurements, the investigators will measure the MUAC evey month for 3 months |
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| 0 |
| 24 |
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Control | The control group is required to eat their normal diet. They are also required to keep a daily food diary. | 1 | 26 | 0 | 26 | 1 | 26 |
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| GI symptoms | Gastrointestinal disorders | Non-systematic Assessment |
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| month 2 |
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| month 3 |
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