UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Healthy Japanese

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

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of Health-Related Quality of Life (HRQL) total score of the overactive bladder questionnaire (OAB-q) at 12 weeks after consumption (12w)

Key secondary outcomes

1. The measured values of HRQL total score of the OAB-q at four and eight weeks after consumption (4w, 8w)

2. The measured values of symptom bother, coping, concern, sleep, and social interaction of the OAB-q at 4w, 8w, and 12w

3. The measured values of each item of the OAB-q at 4w, 8w, and 12w

4. The amount and rate of changes of HRQL total score, symptom bother, coping, concern, sleep, and social interaction between screening (before consumption; Scr) and 4w, 8w, or 12w

5. The measured values of the average frequency of urination in the daytime, in the nighttime, and all day in period 3~14, and the amount and rate of changes of each item from period 1 and period 2*

*Period 1: For 7 days prior to Scr
Period 2: For 7 days prior to initial consumption
Period 3: For 7 days since initial consumption
Period 4: 8~14 days after consumption
Period 5: 15~21 days after consumption
Period 6: 22~28 days after consumption
Period 7: 29~35 days after consumption
Period 8: 36~42 days after consumption
Period 9: 43~49 days after consumption
Period 10: 50~56 days after consumption
Period 11: 57~63 days after consumption
Period 12: 64~70 days after consumption
Period 13: 71~77 days after consumption
Period 14: From 78 days after consumption to the day before 12w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Capsule containing pumpkin seeds extract
Administration: Take one capsule with water two times a day each after breakfast and dinner

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: 12 weeks
Test food: Capsule not containing pumpkin seeds extract
Administration: Take one capsule with water two times a day each after breakfast and dinner

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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

Female

Key inclusion criteria

1. Japanese

2. Women

3. Individuals aged 50 or more

4. Healthy individuals

5. Individuals who are concern about frequency of urination

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

7. Individuals whose score of urinary urgency of overactive bladder symptom score (OABSS) are less than two or whose total score of OABSS are less than three at Scr

8. Individuals whose the measured values of HRQL total score of OAB-q is relatively low at Scr

Key exclusion criteria

Individuals 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 disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products (particularly Cucurbitaceae plants)
7. have allergic or atopic diseases
8. are pregnant, lactating, or planning to become pregnant during this study
9. have been enrolled in other clinical studies within the last 28 days before the agreement to participate or plan to participate another study during this study
10. are judged as ineligible to participate in this study by the physician
11. are undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. overactive bladder, underactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria
12. wake up twice or more to urinate at bedtime
13. have overactive bladder symptom (individuals who urinate eight times or more per day, and have urinary urgency at least once a week)
14. 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)}

Target sample size

20

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

ORTHOMEDICO Inc.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Indena Japan Co., Ltd.

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 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

2023

Year

11

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

24

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

2023

Year

11

Month

15

Day

Date of IRB

2023

Year

11

Month

15

Day

Anticipated trial start date

2023

Year

11

Month

22

Day

Last follow-up date

2024

Year

04

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

22

Day

Last modified on

2024

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060331