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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022128
Receipt No. R000025494
Scientific Title Investigation of the effects of Longvida on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2016/05/02
Last modified on 2018/10/30

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Basic information
Public title Investigation of the effects of Longvida on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Acronym Investigation of the effects of Longvida on cognitive functions
Scientific Title Investigation of the effects of Longvida on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Scientific Title:Acronym Investigation of the effects of Longvida on cognitive functions
Region
Japan

Condition
Condition decline of cognitive function
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the test food to improve cognition in healthy older Japanese adults
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Repeatable Battery for the Assessment of Neuropsychological Status
Hasegawa dementia rating scale
Key secondary outcomes Subjective symptoms: intake 0, 2, 4, 6, 8, 10, 12 weeks
Safety(blood test, history taking):intake 0, 12 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Longvida 400mg/day, 12weeks
Interventions/Control_2 Placebo, 12weeks
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Subjects aged from 50 to 79 years old
2)Japanese male and female
3)Having cognitive complaints
4)Nonsmoker
5)HDS-R score more than 16 points at screening test
Key exclusion criteria 1)Patients under medical treatment
2)Patients under dietetic treatment or ergotherapy
3)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., liver, kidney, endocrine, cardiovascular system, digestive organ, lung, blood, and/or metabolism).
4)Subjects who have undergone gastrointestinal tract surgery; except appendectomy.
5)Subjects who have previous medical history and/or current medical history of mental disorder.
6)Subjects who have previous medical history of drug and/or food allergy.
7)Subjects who have previous medical history and/or current medical history of drug dependence and/or drug abuse.
8)Subjects who participate in other clinical trial within a month
9)Subjects who work time is irregular.
10)Subjects who have previous medical history and/or current medical history of alcoholism
11)Subjects who are in receipt of public assistance
12) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Kondo
Organization Omnica Co.,Ltd
Division name Research team
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9815
Email kondo@omnica.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Iwata
Organization Omnica Co.,Ltd
Division name Research team
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9815
Homepage URL
Email iwata@omnica.co.jp

Sponsor
Institute HUMA R&D Co.
Institute
Department

Funding Source
Organization Omnica Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 28 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025494

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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