UMIN-CTR Clinical Trial

Public title

A study to examine the effect of taking capsules containing olive juice powder (Hytolive) on improving cognitive function

Acronym

A study to examine the effect of taking capsules containing olive juice powder (Hytolive) on improving cognitive function

Scientific Title

A study to examine the effect of taking capsules containing olive juice powder (Hytolive) on improving cognitive function

Scientific Title:Acronym

A study to examine the effect of taking capsules containing olive juice powder (Hytolive) on improving cognitive function

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The study will examine the effect of taking capsules containing olive juice powder (Hytolive) on improving cognitive function in healthy adult men and women aged 50 to 80 years.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cognitrax

Key secondary outcomes

(Secondary outcomes)
MoCa-J,SF-36,WHO-5,BDNF
(Safety evaluation)
Vital signs, body measurements(weight,BMI),blood biochemistry, hematology, adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the test food for 12 weeks

Interventions/Control_2

Intake of the placebo food for 12 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

Age-lower limit

50

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese males and females aged of 50 and 80 at the time of written consent.
2. Subjects who are aware of cognitive decline.
3. Subjects who get 24 or more in score of MMSE-J , 17 or more in score of Moca-J and 5 or less in score of GDS-SF on the SCR test.
4. Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.

Key exclusion criteria

1. Subjects who have been diagnosed with dementia by a physician.
2. Subjects who have taken drugs for dementia, brain metabolism enhancers, thyroid hormones, central nervous system stimulants, antipsychotics, or anticholinergics within 4 weeks prior to the date consent was obtained.
3. Subjects with the following abnormal findings in clinical laboratory values at the time of SCR.
ALT and AST are more than 3 times the upper limit of normal.
Hemoglobin less than 8 g/dL or platelet count less than 100,000/microliter.
4. eGFR less than 60 mL/min/1.73m2.
5. Subjects with cognitive impairment due to brain disease or psychiatric disease.
6. Subjects with thyroid-stimulating hormone (TSH) levels outside the normal range.
7. Subjects with serious mental illnesses such as severe depression, schizophrenia, alcoholism, drug addiction, etc.
8. Subjects with a history of angina pectoris, myocardial infarction, transient ischemic attack, or coronary angioplasty including coronary artery bypass surgery within 6 months prior to the date of obtaining consent.
9. Subjects with a history of severe head injury with loss of consciousness within 6 months of the date of consent.
10. Subjects with a history of acute stroke within 3 months of the date of consent.
11. Have a current or previous history of a serious illness other than those listed above.

Target sample size

80

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Ochitani

Organization

BHN Co., Ltd

Division name

EBF Business Promotion Office

Zip code

101-0054

Address

1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan

TEL

03-5281-5661

Email

d-ochitani@bhn.co.jp

Name of contact person

1st name	Masao
Middle name
Last name	Matsuoka

Organization

M&I Science CORP.

Division name

Clinical Development Department

Zip code

530-0001

Address

Pacific Marks Nishi Umeda 4F, 2-6-20, Umeda, Kita-ku, Osaka-Shi, Osaka, Japan

TEL

06-7878-6780

Homepage URL

Email

m.matsuoka@mis21.co.jp

Institute

others

Institute

Department

Personal name

Organization

others

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Corporation Taifukukai Osaka Nishi-Umeda Clinic Clinical Research Ethics Review Board

Address

Hotel Monterey Osaka (Maruito Nishi-Umeda Building) office floor 3F 3-3-45 Umeda, Kita-ku, Osaka

Tel

06-4797-5660

Email

n-irb@ml.taifukukai.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

11

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2024

Year

10

Month

17

Day

Date of IRB

2024

Year

10

Month

17

Day

Anticipated trial start date

2024

Year

11

Month

26

Day

Last follow-up date

2025

Year

04

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

12. Subjects with severe hearing and vision (visual acuity, visual field, color vision, light perception, etc.) impairment for which efficacy cannot be evaluated.
13. Subjects who are currently pregnant or lactating, or subjects who may be so during the study period.
14. Subjects who have developed allergies as for the foods test.
15. Subjects whose alcohol intake corresponds to the following.
Men: more than 40 g/day, Women: more than 20 g/day (according to WHO daily alcohol intake standards)
16. Excessive smokers (20 cigarettes/day or more)
17. Subjects who have consumed health foods related to cognitive function within 3 months of the start of the study.
18. Subjects who have participated in other clinical trials (research) within the 3 months prior to the date of obtaining consent, or who plan to participate in other clinical trials (research) during the study period.
19. Subjects who have donated more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
20. Subjects who plan to make major changes in their lifestyle (diet, sleep, exercise, etc.) during the study period.
21. Subjects who plan to travel abroadduring the study period.
22. Subjects who have difficulty in recording compliance with various survey forms.
23. Subjects who are judged to be unsuitable as subjects based on clinical laboratory values and measurements at the time of SCR.
24. Other subjects who are judged by the investigator to be unsuitable as subjects.

Registered date

2024

Year

11

Month

20

Day

Last modified on

2025

Year

11

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064215