Trial Outcomes & Findings for MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients (NCT NCT03019458)

NCT ID: NCT03019458

Last Updated: 2020-04-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months

Results posted on

2020-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	24	26
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Death	0	1

Baseline Characteristics

MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MINGO n=24 Participants 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	Control n=26 Participants The control group is required to eat their normal diet. They are also required to keep a daily food diary.	Total n=50 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 1.6 • n=5 Participants	56.4 years STANDARD_DEVIATION 1.6 • n=7 Participants	55.4 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Philippines	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants
Duration of Illness	9.4 years STANDARD_DEVIATION 1.1 • n=5 Participants	8.2 years STANDARD_DEVIATION 1.1 • n=7 Participants	8.8 years STANDARD_DEVIATION 0.8 • n=5 Participants
Body Mass Index (BMI)	18.9 kg/m^2 STANDARD_DEVIATION 0.6 • n=5 Participants	18.2 kg/m^2 STANDARD_DEVIATION 0.4 • n=7 Participants	18.5 kg/m^2 STANDARD_DEVIATION 0.4 • n=5 Participants
Mean Upper Arm Circumference (MUAC)	26.5 cm STANDARD_DEVIATION 0.5 • n=5 Participants	26.5 cm STANDARD_DEVIATION 0.6 • n=7 Participants	26.5 cm STANDARD_DEVIATION 0.4 • n=5 Participants
Burkes-Fahn-Marsden (BFM)	44.1 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants	40.2 units on a scale STANDARD_DEVIATION 4.8 • n=7 Participants	42.1 units on a scale STANDARD_DEVIATION 3.5 • n=5 Participants
Eating Assessment Tool (EAT-10)	20.0 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	19.9 units on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	19.9 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
MGH-Swallowing Screening Tool (MGH-SST)	3.8 units on a scale STANDARD_DEVIATION 0.3 • n=5 Participants	3.8 units on a scale STANDARD_DEVIATION 0.3 • n=7 Participants	3.8 units on a scale STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months

Population: 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

Outcome measures

Outcome measures
Measure	MINGO n=24 Participants 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.	Control n=26 Participants 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
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. week 8	19.15 Kg/m^2 Interval 17.89 to 20.4	18.24 Kg/m^2 Interval 17.24 to 19.24
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. week 12	19.07 Kg/m^2 Interval 17.83 to 20.31	17.95 Kg/m^2 Interval 16.9 to 18.99
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. baseline	18.86 Kg/m^2 Interval 17.66 to 20.06	18.17 Kg/m^2 Interval 17.24 to 19.09
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. week 2	19.00 Kg/m^2 Interval 17.75 to 20.24	18.31 Kg/m^2 Interval 17.3 to 19.31
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. week 4	19.14 Kg/m^2 Interval 17.91 to 20.37	18.27 Kg/m^2 Interval 17.25 to 19.29
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. week 6	19.11 Kg/m^2 Interval 17.9 to 20.33	18.06 Kg/m^2 Interval 17.01 to 19.11
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. week 10	19.03 Kg/m^2 Interval 17.77 to 20.28	18.05 Kg/m^2 Interval 17.01 to 19.1

SECONDARY outcome

Timeframe: 3 months (study close out)

Population: Everyone who enrolled were analyzed

number of deaths in both arms at the end of the study

Outcome measures

Outcome measures
Measure	MINGO n=24 Participants 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.	Control n=26 Participants 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
All Cause Mortality	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months (study close out)

Population: all participants were analyzed

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

Outcome measures

Outcome measures
Measure	MINGO n=24 Participants 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.	Control n=26 Participants 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
Number of Hospitalizations Secondary to Infectious Causes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: After baseline measurements, the investigators will measure the MUAC evey month for 3 months

Population: All participants in the trial

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

Outcome measures

Outcome measures
Measure	MINGO n=24 Participants 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.	Control n=26 Participants 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
Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure baseline	26.54 cm Interval 25.39 to 27.59	26.54 cm Interval 25.24 to 27.84
Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure month 1	26.93 cm Interval 25.86 to 28.0	26.58 cm Interval 25.23 to 27.93
Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure month 2	26.96 cm Interval 25.85 to 28.07	26.69 cm Interval 25.13 to 28.07
Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure month 3	26.69 cm Interval 25.41 to 27.97	26.62 cm Interval 25.03 to 28.18

Adverse Events

MINGO

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MINGO n=24 participants at risk 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	Control n=26 participants at risk The control group is required to eat their normal diet. They are also required to keep a daily food diary.
Gastrointestinal disorders Intolerance to taking MINGO	16.7% 4/24 • Number of events 4 • 3 months	0.00% 0/26 • 3 months
Gastrointestinal disorders GI symptoms	0.00% 0/24 • 3 months	3.8% 1/26 • Number of events 1 • 3 months

Additional Information

Dr. Patrick Acuna

Sunshine Care Foundation

Phone: +63 947 959-1851

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place