UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effects of sweet potato stem/leaf extract - containing soft capsule on cognitive functions in a healthy population: a double-blind, randomized placebo-controlled and parallel study
Title of the study (Brief title)	Investigation of the effects of sweet potato stem/leaf extract - containing soft capsule on cognitive functions
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Cognitrax Alzheimer's Disesase Assessment Scale-cognitive component -Japanese version
Key secondary outcomes	Safety evaluation, Oxidative stress markers in Blood, Brain-derived neurotrophic factor in Blood

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Test food (6 weeks)
Interventions/Control_2	Intake of Test food (6 weeks)
Interventions/Control_3	Intake of Placebo (6 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	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) Diagnosis by the principal investigator: mild cognitive impairment 3) Subjects should have an adequate understanding of the objectives and details of this study and the ability to give written informed consent for participation in the study by themselves
Key exclusion criteria	1) Individuals who take anti-dementia drugs 2) Individuals who take health foods relating cognitive function 3) Individuals judged as dementia for the results of HDS-R by the investigator 4) Individuals judged as depression for the results of GDS-S-J by the investigator 5) Individuals having difficulty in color vision 6) Individuals having difficulty in handling for a injury or operation etc. 7) Individuals who took part in another clinical study (intake of a supplemental food or medicine or composition applied to the skin) within 1 month prior to the start of the present study or who are currently taking part in another clinical study or who are willing to take part in another clinical study. 8) Individuals judged inappropriate for the study by the principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Asada
Organization	Memory clinic Ochanomizu
Division name	Memory clinic Ochanomizu
Address	1-5-34 Yushima, Bunkyou-ku, Tokyo
TEL	03-6801-8718
Email	asada@memory-cl.jp

Public contact
Name of contact person	Hitomi Saito
Organization	FUJIFILM Corporation
Division name	Pharmaceutical & Healthcare Research Laboratories
Address	2-5-1, Suwa, Tama-shi, Tokyo
TEL	080-2119-4836
Homepage URL
Email	Hitomi.saito@fujifilm.com

Sponsor
Institute	Memory clinic Ochanomizu
Institute
Department

Funding Source
Organization	FUJIFILM Corporation
Organization
Division
Category of Funding Organization	Profit organization
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	2018 Year 04 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 04 Day
Anticipated trial start date	2016 Year 08 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	No significant results could be obtained in this trial with the number of participant.
Other related information

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026960