UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease
Title of the study (Brief title)	Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease
Region	Japan

Condition
Condition	Parkinson's Disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the administration effects of the enteral formula enriched with omega-3 fatty acid to nutritional status, ghrelin , leptin and Parkinson's disease clinical evaluation scale in patients with Parkinson's disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Body weight reduction rate ,amount of PD clinical evaluation scale score change (Total score by each part of UPDRS )
Key secondary outcomes	Change rate of albumin, prealbumin, acyl-ghrelin, desacyle-ghrelin, leptin

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	35 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Male and female patients aged 35 years old and above and less than 80 years old at the time of informed consent. 2. Patients who have lost a weight 5% and above unintentionally within past 6 to 12 months. 3. Patients who are capable of consent and have given voluntary written informed consent. 4. Patients who have benefit of L-DOPA drug at the start of administration. 5. Patients who have administrated L-DOPA and DCA combination drugs more than 6 months consecutively. 6. Patients with stable dosage and administration of antiparkingon's disease drugs before 2 weeks of observation period. 7. Patients who are able to follow the study schedule.
Key exclusion criteria	1. Patients with parkinsonian syndrome 2. Patients have participated in the other studies or clinical trials of enteral nutrition formula. 3. Patients who have received surgical treatment such as stereotactic neurosurgery within 6 months. 4. Patients with psychological symptom such as severe confusion, hallucination, delusion and abnormal behavior. 5. Patients with cognitive dysfunction (MMSE score is no more than 21) 6. Patients with a history of drug allergy (Including any ingredient of study drug) 7. Patients who have administrated other study drugs and drug of post-marketing clinical trial within 3 months before observation period and have not completed other studies at the time of informed consent 8. Patients judged to be inappropriate for the study by the investigator.
Target sample size	25

Research contact person
Name of lead principal investigator	Makoto Shiraishi
Organization	St. Mariannna University School of Medicine
Division name	Neurology
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL	044-976-8516
Email	shira@marianna-u.ac.jp

Public contact
Name of contact person	Makoto Shiraishi
Organization	St. Mariannna University School of Medicine
Division name	Neurology
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL	044-976-8516
Homepage URL
Email	shira@marianna-u.ac.jp

Sponsor
Institute	St. Mariannna University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 14 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 30 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009489