MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

• Sponsor: Sunshine Care Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT03019458
• Collaborator: Jose R. Reyes Memorial Medical Center (Other), Massachusetts General Hospital (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 11.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Feb 10, 2017
• Actual Primary Completion Date: May 8, 2017
• Actual Study Completion Date: Jun 26, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. [after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months]

   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.

Secondary Outcome Measures

1. All Cause Mortality [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 [3 months (study close out)]

   number of hospitalizations secondary to infections in both arms at the end of the study

3. Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Centrum	Roxas City	Capiz	Philippines	5800

Sponsors and Collaborators

• Sunshine Care Foundation
• Jose R. Reyes Memorial Medical Center
• Massachusetts General Hospital

Investigators

• Principal Investigator: Criscely L Go, MD,FPNA,DPBP, Jose R. Reyes Memorial Medical Center

Study Documents (Full-Text)

• Study Protocol - Jan 25, 2017
• Statistical Analysis Plan - Nov 11, 2016

More Information

Publications

None provided.

• Responsible Party: Sunshine Care Foundation
• ClinicalTrials.gov Identifier: NCT03019458
• Other Study ID Numbers: MINGO-001
• First Posted: Jan 12, 2017
• Last Update Posted: Apr 30, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Dystonia; Dystonic Disorders; Parkinsonian Disorders; Genetic Diseases, X-Linked

Study Results

Participant Flow

Arm/Group Title	MINGO	Control
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	24	26
COMPLETED	24	25
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	MINGO	Control	Total
Arm/Group Description	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	The control group is required to eat their normal diet. They are also required to keep a daily food diary.	Total of all reporting groups
Overall Participants	24	26	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.2 (1.6)	56.4 (1.6)	55.4 (1.2)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	24 100%	26 100%	50 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	24 100%	26 100%	50 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Philippines	24 100%	26 100%	50 100%
Duration of Illness (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.4 (1.1)	8.2 (1.1)	8.8 (0.8)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	18.9 (0.6)	18.2 (0.4)	18.5 (0.4)
Mean Upper Arm Circumference (MUAC) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	26.5 (0.5)	26.5 (0.6)	26.5 (0.4)
Burkes-Fahn-Marsden (BFM) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	44.1 (5.3)	40.2 (4.8)	42.1 (3.5)
Eating Assessment Tool (EAT-10) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.0 (2.3)	19.9 (2.6)	19.9 (1.7)
MGH-Swallowing Screening Tool (MGH-SST) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.8 (0.3)	3.8 (0.3)	3.8 (0.2)

Outcome Measures

1. Primary Outcome

Title	The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	MINGO	Control
Arm/Group Description	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.	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
Measure Participants	24	26
baseline	18.86	18.17
week 2	19.00	18.31
week 4	19.14	18.27
week 6	19.11	18.06
week 8	19.15	18.24
week 10	19.03	18.05
week 12	19.07	17.95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MINGO, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.084
	Comments	The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p<0.05.
	Method	Mixed Models Analysis
	Comments	We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).

2. Secondary Outcome

Title	All Cause Mortality
Description	number of deaths in both arms at the end of the study
Time Frame	3 months (study close out)

Outcome Measure Data

Analysis Population Description

Everyone who enrolled were analyzed

Arm/Group Title	MINGO	Control
Arm/Group Description	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.	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
Measure Participants	24	26
Count of Participants [Participants]	0 0%	1 3.8%

3. Secondary Outcome

Title	Number of Hospitalizations Secondary to Infectious Causes
Description	number of hospitalizations secondary to infections in both arms at the end of the study
Time Frame	3 months (study close out)

Outcome Measure Data

Analysis Population Description

all participants were analyzed

Arm/Group Title	MINGO	Control
Arm/Group Description	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	The control group is required to eat their normal diet. They are also required to keep a daily food diary.
Measure Participants	24	26
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure
Description	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

Outcome Measure Data

Analysis Population Description

All participants in the trial

Arm/Group Title	MINGO	Control
Arm/Group Description	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	The control group is required to eat their normal diet. They are also required to keep a daily food diary.
Measure Participants	24	26
baseline	26.54	26.54
month 1	26.93	26.58
month 2	26.96	26.69
month 3	26.69	26.62

Adverse Events

Time Frame	3 months
Arm/Group Title	MINGO		Control
Arm/Group Description	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		The control group is required to eat their normal diet. They are also required to keep a daily food diary.
All Cause Mortality
	MINGO		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/26 (3.8%)
Serious Adverse Events
	MINGO		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	MINGO		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/24 (16.7%)		1/26 (3.8%)
Gastrointestinal disorders
Intolerance to taking MINGO	4/24 (16.7%)	4	0/26 (0%)	0
GI symptoms	0/24 (0%)	0	1/26 (3.8%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.