Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03019458
Other study ID # MINGO-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2017
Est. completion date June 26, 2017

Study information

Verified date April 2020
Source Sunshine Care Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 26, 2017
Est. primary completion date May 8, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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)

Study Design


Intervention

Dietary Supplement:
MINGO
6 20oz sachets will be taken daily by intervention group

Locations

Country Name City State
Philippines Health Centrum Roxas City Capiz

Sponsors (3)

Lead Sponsor Collaborator
Sunshine Care Foundation Jose R. Reyes Memorial Medical Center, Massachusetts General Hospital

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
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. after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
Secondary All Cause Mortality number of deaths in both arms at the end of the study 3 months (study close out)
Secondary Number of Hospitalizations Secondary to Infectious Causes number of hospitalizations secondary to infections in both arms at the end of the study 3 months (study close out)
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 After baseline measurements, the investigators will measure the MUAC evey month for 3 months
See also
  Status Clinical Trial Phase
Available NCT05592028 - High Intensity Focused Ultrasound for X-linked Dystonia-parkinsonism