UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on urination in healthy Japanese subjects

Acronym

Effects of consumption of the test food on urination in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on urination in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group study

Scientific Title:Acronym

Effects of consumption of the test food on urination in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on urination in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured values of "frequent urination during the daytime hours" of "symptom bother" of Overactive Bladder questionnaire (OAB-q) at 12 weeks after consumption (12w)

Key secondary outcomes

1. The amount of change of "frequent urination during the daytime hours" of "symptom bother" of OAB-q between screening (before consumption: Scr) and 12w

2. The measured values and amount of change from Scr of "symptom bother", "the effect of QOL", "coping", "concern", "sleep", and "social interaction" of OAB-q at 12w

3-1*. The average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV

3-2*. The amout chande from period I of average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV

3-3*. The amout chande from period II of average frequency of urination in the daytime, in the nighttime, and all day in each period III to period XIV

*Period I: 7 days prior to Scr
Period II: 7 days from 1 week prior to the start of intake to the day before the start of consumption
Period III: 1st week of the start of consumption
Period IV: 2nd week of the start of consumption
Period V: 3rd week of the start of consumption
Period VI: 4th week of the start of consumption
Period VII: 5th week of the start of consumption
Period VIII: 6th week of the start of consumption
Period IX: 7th week of the start of consumption
Period X: 8th week of the start of consumption
Period XI: 9th week of the start of consumption
Period XII: 10 weeks of the start of consumption
Period XIII: 11th week of the start of consumption
Period XIV: 12th week of the start of consumption

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Capsule containing saw palmetto extracts
Administration: Take one capsule with water between after dinner to before going to bed

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test food: Capsule not containing saw palmetto extracts
Administration: Take one capsule with water between after dinner to before going to bed

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Subjects aged 50 or more

4. Healthy subjects

5. Subjects who are concern about frequency of urination

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose high sensitive prostate-specific antigen (PSA) value are less than 4 ng/mL at Scr at Scr

8. Subjects whose score of urinary urgency of overactive bladder symptom score (OABSS) are less than two or total score of OABSS are less than three

9. Subjects whose average daytime urinary frequency are eight and more and less than ten times in seven days before Scr

10. Subjects whose "frequent urination during the daytime hours" of "symptom bother" of OAB-q are relatively high

Key exclusion criteria

Subjects who

1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. plan to have surgery from first consumption to two weeks after last consumption

5. are undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria

6. wake up twice or more to urinate at bedtime

7. have overactive bladder symptom (subjects who urinate eight times or more per day, and have urinary urgency at least once a week)

8. drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

9. use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily

10. are currently taking medications (including herbal medicines) and supplements

11. are allergic to medicines and/or the test food related products

12. are pregnant, breast-feeding, and planning to become pregnant

13. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

14. are judged as ineligible to participate in the study by the physician

Target sample size

62

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

YAWATA CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2021

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

68

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

2021

Year

08

Month

25

Day

Date of IRB

2021

Year

08

Month

25

Day

Anticipated trial start date

2021

Year

09

Month

02

Day

Last follow-up date

2022

Year

04

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

09

Month

01

Day

Last modified on

2024

Year

04

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051771