UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047751
Receipt number R000054389
Scientific Title A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2022/05/13
Last modified on 2022/05/10 17:17:46

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Basic information

Public title

A Study on the Effect of Test food on Subjective symptoms in Aging Men
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

Acronym

A Study on the Effect of Test food on Subjective symptoms in Aging Men

Scientific Title

A Study on the Effect of Test food on Subjective symptoms in Aging Men
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

Scientific Title:Acronym

A Study on the Effect of Test food on Subjective symptoms in Aging Men

Region

Japan


Condition

Condition

No

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effect of test food on subjective symptoms in aging men

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

questionnaire

Key secondary outcomes



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

Treatment

Type of intervention

Food

Interventions/Control_1

Active food A,
8 weeks consumption

Interventions/Control_2

Active food B,
8 weeks consumption

Interventions/Control_3

Placebo food,
8 weeks consumption

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

35 years-old <=

Age-upper limit

65 years-old >

Gender

Male

Key inclusion criteria

1) Healthy males aged 35 to 64 years-old.
2) Subjects who are aware of feelings of decreased libido, etc.
3) Subjects whose total testosterone levels in blood are 250 ng/dL or over.
4) Subjects whose BMI are less than 30.
5) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1) Subjects who contract sexual dysfunction (erectile dysfunction, etc.).
2) Subjects who contract, are under treatment for serious diseases (e.g., diabetes, kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
3) Subjects who have a chronic disease and regularly use medications.
4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
5) Subjects who are judged as unsuitable for the current study by screening test.
6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims).
7) Subjects who have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking 4 or more days per week.
8) Subjects who can't stop drinking from a day before each measurement.
9) Subjects who have declared allergic reaction to ingredients of test food.
10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
11) Subjects who are shiftworker and/or midnight-shift worker.
12) Subjects who plan to travel abroad, including overseas travel, during test periods.
13) Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

eigyou27@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

TOYO SHINYAKU Co., Ltd.

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

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17 Joto-machi, Maebashi-shi, Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp


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

2022 Year 05 Month 13 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


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

Preinitiation

Date of protocol fixation

2022 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2022 Year 05 Month 14 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 05 Month 13 Day

Last modified on

2022 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054389


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name