UMIN-CTR Clinical Trial

Public title

An investigation on the effect of glucosamine intake on improving bowel movements

Acronym

Effect of glucosamine on improving bowel movements

Scientific Title

An investigation on the effect of glucosamine intake on improving bowel movements -Open Label Single Arm Trial-

Scientific Title:Acronym

Effect of glucosamine on improving bowel movements -Single Arm Trial-

Region

Japan

Condition

Constipation tendency in adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of glucosamine intake on improving the intestinal environment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Bowel movements (the previous observation period (2 weeks) and the 2 weeks-intake period after starting intake)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of glucosamine 1500mg per day for 14 days

Interventions/Control_2

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

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Japanese men and women aged 20 to 59 at the time of consent
2) Subjects with a bowel movement frequency of 3 to 5 times per week

Key exclusion criteria

1) Those taking medicines that may affect the test results (medicines with intestinal regulating effects, antibiotics, etc.)
2) Those who regularly consume health foods that may affect the test results (lactic acid bacteria, oligosaccharides, supplements that claim to regulate the intestines, etc.) or health foods that contain the same main ingredients as the test product
3) Pregnant or potentially pregnant women, and breastfeeding women
4) Those with alcoholism
5) Those who may have allergic reactions to the test product ingredients
6) Those participating in other clinical trials
7) Those with a history of severe liver damage, kidney damage, or heart disease
8) Those with a history of hepatitis or current illness
9) Those with severe anemia

Target sample size

20

Name of lead principal investigator

1st name	Tomoya
Middle name
Last name	Shintani

Organization

TOYO INSTITUTE of FOOD TECHNOLOGY

Division name

Research department

Zip code

666-0026

Address

4-23-2 Minami-Hanayashiki, Kawanishi, Hyogo 666-0026, Japan

TEL

072-740-3300

Email

tomoya_shintani@shokuken.or.jp

Name of contact person

1st name	Tomoya
Middle name
Last name	Shintani

Organization

TOYO INSTITUTE of FOOD TECHNOLOGY

Division name

Research department

Zip code

666-0026

Address

4-23-2 Minami-Hanayashiki, Kawanishi, Hyogo 666-0026, Japan

TEL

072-740-3300

Homepage URL

Email

tomoya_shintani@shokuken.or.jp

Institute

SOUKEN Co., Ltd.

Institute

Department

Personal name

Organization

TOYO INSTITUTE of FOOD TECHNOLOGY

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Shiba Palace Clinic Institutional Review Board

Address

1-9-10, DaiwaA Hamamatsucho Building 3rd floor, Hamamatsucho, Minato-ku, Tokyo, Japan

Tel

03-5408-1555

Email

jimukyoku@mail.souken-r.com

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

2025

Year

02

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.medrxiv.org/content/10.1101/2025.06.15.25329540v1

Number of participants that the trial has enrolled

29

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

Main results already published

Date of protocol fixation

2025

Year

01

Month

16

Day

Date of IRB

2025

Year

01

Month

16

Day

Anticipated trial start date

2025

Year

01

Month

30

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1)
Based on the study plan, the following subject management items were established. Whether subjects complied with these items, along with whether they took the test product, was confirmed through an "Intake status diary."
[Subject management items] During the study period, subjects maintained the same living environment (sleep, diet, general lifestyle) as before the study began.

2)
In analyzing the number of participants using power analysis, we determined the sample size to ensure 80% statistical power under the condition of analysis using a two-group paired t-test assuming a moderate effect size (Cohen's d) (0.5). However, because it was difficult to conduct the study with 34 participants, we referred to previous studies and reduced the target number of participants to the range considered possible for detection, setting the target number at 20.

Registered date

2025

Year

01

Month

20

Day

Last modified on

2025

Year

10

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064864