UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023401
Receipt number R000026960
Scientific Title 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
Date of disclosure of the study information 2018/04/29
Last modified on 2019/03/05 10:27:51

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Basic information

Public title

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

Acronym

Investigation of the effects of sweet potato stem/leaf extract - containing soft capsule on cognitive functions

Scientific Title

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Takashi Asada

Organization

Memory clinic Ochanomizu

Division name

Memory clinic Ochanomizu

Zip code


Address

1-5-34 Yushima, Bunkyou-ku, Tokyo

TEL

03-6801-8718

Email

asada@memory-cl.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitomi Saito

Organization

FUJIFILM Corporation

Division name

Pharmaceutical & Healthcare Research Laboratories

Zip code


Address

2-5-1, Suwa, Tama-shi, Tokyo

TEL

080-2119-4836

Homepage URL


Email

Hitomi.saito@fujifilm.com


Sponsor or person

Institute

Memory clinic Ochanomizu

Institute

Department

Personal name



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)



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

2018 Year 04 Month 29 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

No significant results could be obtained in this trial with the number of participant.

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 07 Month 04 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026960


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name