UMIN-CTR Clinical Trial

Public title

A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulin

Acronym

A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulin

Scientific Title

A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulinbasal metabolism: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulin

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the improving effects of consumption of food containing Bifidobacterium animalis subsp. lactis GCL2505 and inulin on resting energy metabolism in a randomized, placebo-controlled, double-blind, parallel-group comparison study with respiratory metabolism measurement

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Resting energy expenditure at four weeks after consumption (4w)

Key secondary outcomes

1. Resting energy expenditure at two weeks after consumption (2w)
2. Respiratory quotient, energy expenditure, muscle mass, skeletal muscle mass, body fat percentage, body fat mass, acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and fecal Bifidobacterium at 2w and 4w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test beverage: Milk beverage containing 10 billion Bifidobacterium animalis subsp. lactis GCL2505 and 2 g of inulin
Administration: Take one bottle (100 g) once daily after breakfast

*If you forget to take the test beverage, 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: Four weeks
Test beverage: Placebo milk beverage
Administration: Take one bottle (100 g) once daily after breakfast

*If you forget to take the test beverage, 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

25

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Men and women aged 25 or more and 60 or less
2) Subjects whose BMI are 25 kg/m² or more and less than 30 kg/m² at screening
3) Fully informed of the purpose and content of the study, deemed to have the capacity to consent, and volunteered of their own accord to participate in the study based on a thorough understanding of the purpose and content of the study, and provided written informed consent to participate in the study.

Key exclusion criteria

1)Subjects who are undergoing medical treatment of chronic diseases
2)Treatment for severe kidney disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, other metabolic diseases, diabetes, or other illness (excluding transient illnesses such as colds)
3)use of antibiotics within 1 month prior to the start of the study
4)regularly use intestinal drugs and laxatives (including strong laxatives)
5)unable to stop intake of health foods or supplements that affect energy metabolism
6)unable to restrict the intake of foods that might affect the intestinal microbiota
7)Who regularly consume yogurt, lactic fermenting beverages, and foods with intestinal function (those who can discontinue consumption from the screening test to the end of the study are allowed), and those who cannot stop consuming probiotics, fermented foods, and foods containing high amounts of oligosaccharides.
8)who cannot abstain from alcohol for 2 days prior to each test.
9)who are unable to fast for 12 hours prior to the metabolic rate measurement or are unable to consume 3 meals of the prescribed foods.
10)who cannot have a stool sample taken during the specified period or cannot arrange for shipping.
11)Smokers
12)history of allergy to any of the study food ingredients
13)current or former drug or alcohol dependence
14)Shift workers or late-night workers
15)who exercise regularly (about 60 minutes per week of breathless and sweaty exercise)
16)who have a cardiac pacemaker, implantable cardioverter-defibrillator, or who have metal in the measurement site due to surgery, etc.
17)who are pregnant, lactating, or planning to become pregnant during this trial
18)who are participating, or intend to participate during the study period, in a study involving the ingestion of other foods or the use of drugs, or the application of cosmetics or drugs.
19)deemed ineligible by the principal investigator.

Target sample size

40

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

Name of contact person

1st name	Eiji
Middle name
Last name	Yoshikawa

Organization

KSO Corporation

Division name

Clinical Trial Management department

Zip code

105-0023

Address

1-9-7, Shibaura, Minato-ku, Tokyo, The 7th floor of Shibaura omodaka building

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Ezaki Glico Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

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

Tel

027-212-5608

Email

sagawa@mc-connect.co.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

12

Month

17

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

Preinitiation

Date of protocol fixation

2023

Year

10

Month

12

Day

Date of IRB

2023

Year

10

Month

12

Day

Anticipated trial start date

2023

Year

11

Month

06

Day

Last follow-up date

2024

Year

01

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

02

Day

Last modified on

2023

Year

11

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060122