UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052435 |
|---|---|
| Receipt number | R000059847 |
| Scientific Title | A verification study of the improving effect of consumption of the test beverage on resting energy expenditure: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/16 18:47:38 |
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Basic information
Public title
A verification study of the improving effect of consumption of the test beverage on resting energy expenditure
Acronym
A verification study of the improving effect of consumption of the test beverage on resting energy expenditure
Scientific Title
A verification study of the improving effect of consumption of the test beverage on resting energy expenditure: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A verification study of the improving effect of consumption of the test beverage on resting energy expenditure
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o verify the improving effects of consumption of food containing Bifidobacterium animalis subsp. lactis GCL2505 and inulin on basal 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
Assessment
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, glucose oxidation rate, carbohydrate oxidation rate, fat oxidation rate, basal metabolic rate, body mass index (BMI), body weight, basal metabolism, body fat percentage, muscle mass, acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and Bifidobacterium in the stool at 2w and 4w
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
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 5 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
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 25 or more and 60 or less
4. Healthy subjects
5. Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2
6. Subjects with body fat percentage of 15% or more for men and 25% or more for women
7. The bottom 40 subjects with low resting metabolism among those who meet inclusion criteria No.1~6 without meeting any of exclusion criteria
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims"
5. Subjects who are taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test beverage related products
7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who 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
9. Subjects who have taken antibiotics within the last 28 days before the agreement to participate in this trial
10. Subjects who are judged as ineligible to participate in this study by the physician
Target sample size
40
Research contact person
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
t-takara@takara-clinic.com
Public contact
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
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
IRB@takara-clinic.com
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
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)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/16/14/2345
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/16/14/2345
Number of participants that the trial has enrolled
44
Results
Participants consumed a test beverage containing 1 * 10^10 colony-forming units of Bifidobacterium animalis subsp. lactis GCL2505 per 100 g and 5.0 g of inulin per 100 g for 4 weeks. The resting energy expenditure of the GCL2505 and inulin group was significantly higher than that of the placebo group at weeks 2 and 4. The intervention significantly increased the total number of bifidobacteria.
Results date posted
| 2024 | Year | 10 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 20 | Day |
Baseline Characteristics
44 healthy subjects between the ages of 25 and 61 years(12 males and 32 females, Age(Active group):47.75(11.07), Age(Placebo group):47.75(9.68), Height(Active group):160.18(6.44)cm, Height(Placebo group):157.50(6.45)cm, Weight(Active group):68.61(8.37)kg, Weight(Placebo group):66.86(6.21)kg, BMI(Active group):26.65(1.47), BMI(Active group):26.90(1.02))
All data are presented as mean (SD).
Participant flow
Number of Intention To Treat: 44
Number of Full Analysis Set: 43
Number of Per Protocol Set: 40
Adverse events
Nothing
Outcome measures
Resting energy expenditure at four weeks after consumption (4w), Resting energy expenditure at two weeks after consumption (2w), Respiratory quotient, energy expenditure, glucose oxidation rate, carbohydrate oxidation rate, fat oxidation rate, basal metabolic rate, body mass index (BMI), body weight, basal metabolism, body fat percentage, muscle mass, acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and Bifidobacterium in the stool at 2w and 4w
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059847
