MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

NCT ID: NCT03019458

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2017-06-26

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.

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.

Conditions

X-Linked Dystonia Parkinsonism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MINGO

Intervention Type: DIETARY_SUPPLEMENT

6 20oz sachets will be taken daily by intervention group

Control

The control group is required to eat their normal diet. They are also required to keep a daily food diary.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MINGO

6 20oz sachets will be taken daily by intervention group

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jose R. Reyes Memorial Medical Center

OTHER_GOV

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Sunshine Care Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Criscely L Go, MD,FPNA,DPBP

Role: PRINCIPAL_INVESTIGATOR

Jose R. Reyes Memorial Medical Center

Locations

Health Centrum

Roxas City, Capiz, Philippines

Countries

Philippines

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MINGO-001

Identifier Type: -

Identifier Source: org_study_id