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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039292
Receipt No. R000044818
Scientific Title Effect of Daily Ingestion of Konjac-origin Glucosylceramide on Cognitive function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study-Pilot Study-
Date of disclosure of the study information 2020/01/28
Last modified on 2020/01/28

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Basic information
Public title Effect of Daily Ingestion of Konjac-origin Glucosylceramide on Cognitive function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study-Pilot Study-
Acronym Beneficial Effects of Konjac-origin Glucosylceramide on Cognitive function
Scientific Title Effect of Daily Ingestion of Konjac-origin Glucosylceramide on Cognitive function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study-Pilot Study-
Scientific Title:Acronym Beneficial Effects of Konjac-origin Glucosylceramide on Cognitive function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate clinical benefits associated with 24 week daily ingestion of Konjac-origin Glucosylceramide on cognitive function in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes MMSE and plasma amyloid be-ta composite biomarker at 24 weeks after beginning the ingestion of test food.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily ingestion 30 g of jelly containing konjac-origin glucosylceramide for 24 weeks.
Interventions/Control_2 Daily ingestion 30 g of placebo jelly for 24 weeks.
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2.Subjects who are aware of their cognitive decline such as forgetfulness.
3.Subjects who can carry out cognitive function test, write diary and questionnaire.
Key exclusion criteria 1.Subjects whose MMSE score is <= 23 points.
2.Subjects with unusually high and/or low plasma amyloid be-ta.
3.Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease.
4.Subjects with a history of (or suspected) psychiatric disorder and
cerebrovascular disease.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
7. Subjects with unusually high and/or low blood pressure and/or abnormal physical data and hematological data.
8. Subjects with severe anemia.
9. Pre- or post-menopausal women complaining of obvious physical changes.
10. Subjects with dysphagia.
11. Subjects who are at risk of having allergic reactions to drugs or foods especially based on gelatin, mango, urushi, pistachio, cashew nut, latex rubber and birch.
12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect cognitive function.
13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
14. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Hokkaido University
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The ethics committee of Hokkaido Information University
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel 011-385-4411
Email soumu@do-johodai.ac.jp

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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 28 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 22 Day
Date of IRB
2020 Year 01 Month 22 Day
Anticipated trial start date
2020 Year 02 Month 19 Day
Last follow-up date
2020 Year 10 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 28 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044818

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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