UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048386 |
|---|---|
| Receipt number | R000055154 |
| Scientific Title | A study to confirm the effect of continuous ingestion of bifidobacteria and dietary fiber-containing beverages to improve cognitive function: A randomized, double-blind, placebo-controlled, parallel group comparison study. |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/10/22 14:38:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to confirm the effect of continuous ingestion of bifidobacteria and dietary fiber-containing beverages to improve cognitive function: A randomized, double-blind, placebo-controlled, parallel group comparison study.
Acronym
A study to confirm the effect of continuous ingestion of bifidobacteria and dietary fiber-containing beverages to improve cognitive function.
Scientific Title
A study to confirm the effect of continuous ingestion of bifidobacteria and dietary fiber-containing beverages to improve cognitive function: A randomized, double-blind, placebo-controlled, parallel group comparison study.
Scientific Title:Acronym
A study to confirm the effect of continuous ingestion of bifidobacteria and dietary fiber-containing beverages to improve cognitive function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax after 12 weeks of ingestion
Key secondary outcomes
Cognitrax after 8 weeks of ingestion
SF-36
Fecal bifidobacteria
Blood inflammatory marker
Blood BDNF
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion 100 g of the drink containing bifidobacterium and dietary fiber for 12 weeks.
Interventions/Control_2
Daily ingestion 100 g of the drink not containing bifidobacterium and dietary fiber for 12 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females from 50 to 79 years old at the time of the informed.
2.Subjects who get 24 or more in score of Mini Mental State Examination-Japanese (MMSE-J) , 17 or more in score of Montreal Cognitive Assessment-Japanese version (Moca-J) and 5 or less in score of The Geriatric Depression Scale-Short Form-Japanese (GDS-S-J).
3. Subjects who have the subjective symptom of forgetfulness, or who have been pointed out by relatives or acquaintances that they have objective symptoms of forgetfulness.
4. Subjects who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria
1. Subjects who are in the hospital or have a history of mental disorders (including depressive symptoms), cerebrovascular diseases, and sleep disorders.
2. Subjects who with severe liver, kidney, heart, respiratory organs, endocrine and metabolic diseases.
3. Smokers.
4. Alcohol addicts (those who drink 60 g or more of pure alcohol every day) and subjects with extremely irregular eating habits.
5. Subjects who cannot comply with restrictions on foods and supplements that affect the intestinal environment during in this study.
6. Subjects who took antibiotics within one month from the start date of this study.
7. Subjects who have undergone gastrointestinal surgery (excluding appendicitis).
8. Subjects who have experienced allergies to research food ingredients.
9. Subjects who taking medications (antipsychotics, anxiolytics, antidepressants, anti-Parkinson's diseases, antidepressants, antiepileptic drugs, anti-blood coagulants, etc.) that may affect cognitive function.
10. Subjects with impaired cognitive function tests due to impaired eyesight and hearing.
11. Subjects who routinely take foods and supplements that may affect cognitive function.
12. Subjects with current or a history of drug or alcohol dependence.
13. Subjects who are participating in research on ingestion of other foods or using medicines, research on applying cosmetics and medicines, subjects who participate in other research while participating in this study.
14. Subjects who are considered as an inappropriate candidate by the doctor in charge.
Target sample size
80
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
yiwama@well-sleep.jp
Public contact
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
TEL
03-3452-7733
Homepage URL
eigyou@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
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
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
| 2023 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/15/19/4175
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/15/19/4175
Number of participants that the trial has enrolled
80
Results
Results showed that the active group had significantly improved scores in the domains of complex attention, cognitive flexibility, and executive function, as well as in the domain of neurocognitive index, an assessment of overall cognitive function, compared to the placebo group. In addition, the number of bifidobacteria in the feces of the active group was significantly increased versus the placebo group, and the values of several serum inflammatory markers were significantly reduced.
Results date posted
| 2023 | Year | 10 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 27 | Day |
Baseline Characteristics
Participant flow
Number of Intention To Treat: 80
Number of Full Analysis Set: 79
Number of Per Protocol Set: 67
Adverse events
Nothing
Outcome measures
Cognitrax after 12 weeks of ingestion.
Cognitrax after 8 weeks of ingestion.
SF-36
Fecal bifidobacteria
Blood inflammatory marker
Blood BDNF
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 13 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055154
