UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043494 |
|---|---|
| Receipt number | R000049662 |
| Scientific Title | Efficacy of the mixture of Gingko biloba extract with Sesame extract and Turmeric oil on cognitive function in healthy adults: a 24 weeks, randomized double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2023/09/02 09:32:47 |
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Basic information
Public title
Association of the simultaneous administration of Gingko biloba extract and absorption promoting agent with cognitive function
Acronym
Association of Gingko biloba extract with cognitive function
Scientific Title
Efficacy of the mixture of Gingko biloba extract with Sesame extract and Turmeric oil on cognitive function in healthy adults: a 24 weeks, randomized double-blind, placebo-controlled trial
Scientific Title:Acronym
Association of "Gingko biloba extract with Sesame extract and Turmeric oil" with cognitive function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the influence of the mixture of Gingko biloba extract with improved bioavailability agents on the alteration of cognitive function in healthy adults.
Basic objectives2
Others
Basic objectives -Others
The primary aim of this study is to discover the influence of the mixture of Gingko biloba extract, Sesame extract and Turmeric oil (GBE/MST) on the alteration of cognitive function assessed by neuropsychological examinations.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint of this study is to discover any alteration of cognitive function in healthy adults assessed by Wechsler Memory Scale revised (WMS-R) following 24 weeks administration of GBE/MST.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Two capsules of GBE/MST supplement, once a day for 24 weeks
Interventions/Control_2
Two capsules of GBE supplement, once a day for 24 weeks
Interventions/Control_3
Two capsules of placebo, once a day for 24 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who is confirmed with a written informed consent. Normal cognitive function at baseline is confirmed by Montreal Cognitive Assessment battery Japanese version (more than 26).
Key exclusion criteria
1) With past history of severe neurological diseases.
2) With critical bleeding incidents.
3) Use of antithrombotic medicine.
4) Severe depression
5) Patients with diabetes mellitus.
6) With severe visual or auditory disability.
7) Individuals with any metal implantation, such as cardiac pacemaker, coronary stent and artificial joint.
8) Claustrophobia.
9) Use of any supplement.
10) Creatinine clearance less than 15ml/min.
11) Patients with gastrointestinal diseases or metabolic diseases.
12) Diagnosed psychiatric disorders.
13) Participants who cannot obtain the informed consent.
14) Allergy to the study materials.
15) Individuals who is not suitable for participating in this study decided by principal investigator.
Target sample size
159
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
IDAC, Tohoku University
Division name
Department of Aging Research and Geriatric Medicine
Zip code
980-8575
Address
4-1 Seiryo Cho, Aoba Ku, Sendai, Miyagi
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Taizen |
| Middle name | |
| Last name | Nakase |
Organization
IDAC, Tohoku University
Division name
Department of Aging Research and Geriatric Medicine
Zip code
980-8575
Address
4-1 Seiryo Cho, Aoba Ku, Sendai, Miyagi
TEL
022-717-8559
Homepage URL
taizen.nakase.a4@tohoku.ac.jp
Sponsor or person
Institute
Department of Aging Research and Geriatric Medicine
IDAC, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ooki Pharmaceutical Company
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
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1 Seiryo Cho, Aoba Ku, Sendai, Miyagi
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
東北大学加齢医学研究所
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0280549
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
155
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
| 2021 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049662
