UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039442 |
|---|---|
| Receipt number | R000044970 |
| Scientific Title | Effects of the test food on intestinal microbiome. |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2026/08/16 11:42:09 |
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Basic information
Public title
Effects of the test food on intestinal microbiome.
Acronym
Effects of the test food on intestinal microbiome.
Scientific Title
Effects of the test food on intestinal microbiome.
Scientific Title:Acronym
Effects of the test food on intestinal microbiome.
Region
| Japan |
Condition
Condition
healthy humans
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of intake of the test food on intestinal microbiome in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal microbiome
Key secondary outcomes
Oxidative stress in feces
Biochemical analysis (saliva)
Amylase
IL-6
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the water (530ml/day) for 8 weeks
Interventions/Control_2
Intake of the test food A (300ml) for 8 weeks
Interventions/Control_3
Intake of the test food B (20g) for 8 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women over 20 years old
(2) Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria
(1)Subjects who has treatment with warfarin.
(2)Subjects with the severe disease medical history.
(3)Subjects with the gastric hyperacidity.
(4)Subjects who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators.
(5)When the subject wants to stop the measurement.
(6)When the examiner determines that measurement is difficult.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadayuki |
| Middle name | |
| Last name | Iida |
Organization
Prefectural University of Hiroshima.
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara City, Hiroshima Pref. 723-0053, Japan
TEL
0848-60-1196
iida@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Tadayuki |
| Middle name | |
| Last name | Iida |
Organization
Prefectural University of Hiroshima.
Division name
Department of Physical Therapy, Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara City, Hiroshima Pref. 723-0053, Japan
TEL
0848-60-1196
Homepage URL
iida@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima.
Institute
Department
Personal name
Funding Source
Organization
SAPPORO HOLDINGS LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SAPPORO HOLDINGS LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima.
Address
1-1 Gakuen-cho, Mihara City, Hiroshima Pref. 723-0053, Japan
Tel
0848-60-1120
yosikawa@pu-hiroshima.ac.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 | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://seronjihou.com/wp-content/uploads/2021/12/286625.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://seronjihou.com/wp-content/uploads/2021/12/286625.pdf
Number of participants that the trial has enrolled
10
Results
All 10 participants completed the study and were included in the analysis. Comparing the changes in microbial abundance between the two groups, a statistically significant difference was observed in the genus Bilophila (decrease in the lemon water group, p = 0.036). Additionally, marginally significant differences were observed in the genera Adlercreutzia (p = 0.095), Haemophilus (p = 0.076), Megamonas (p = 0.095), and Roseburia (p = 0.065).
Results date posted
| 2026 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
[Overall (N=10)]
10 healthy male university students
- Age: 22.1(1.1) years
- Height: 173.1(4.6) cm
- Weight: 63.0(6.5) kg
[Group Characteristics]
1. Water Group (n=5):
- Age: 21.6(1.4) years
- Height: 172.6(5.7) cm
- Weight: 63.9(7.6) kg
2. Lemon Water Group (n=5):
- Age: 22.6(1.3) years
- Height: 173.7(3.9) cm
- Weight: 62.1(6.0) kg
*Exclusion criteria: Warfarin therapy, history of severe disease, or hyperacidity.
Participant flow
[Enrollment and Allocation]
Ten healthy male subjects provided informed consent and were randomly assigned in a 1:1 ratio to the following two groups:
- Water Group: n = 5
- Lemon Water Group: n = 5
[Intervention]
- Water Group (n = 5): Consumed 300 mL/day of water before meals for 4 weeks. No dropouts (5 continued).
- Lemon Water Group (n = 5): Consumed 300 mL/day of 10% lemon water before meals for 4 weeks. No dropouts (5 continued).
[Follow-up and Analysis]
After the 4-week intervention period, fecal samples were collected from all participants in both groups.
There were no dropouts or exclusions from the analysis.
- Water Group: n = 5 (analyzed)
- Lemon Water Group: n = 5 (analyzed)
(All 10 participants completed the protocol and were included in the final analysis.)
Adverse events
[Presence of Adverse Events]
None (No adverse events observed)
[Details/Summary]
During the 4-week intervention period, no serious adverse events or clinically significant health problems related to the test food (10% lemon water) or control (water) consumption were reported.
Outcome measures
[Primary Outcome]
1. Changes in gut microbiota composition and relative abundance
- Time point: Baseline and after 4 weeks of intervention
- Measurement tool:using a next-generation sequencer (MiSeq) with fecal samples, evaluated at the genus level (relative abundance %).
- Outcome summary:
- A statistically significant difference in the relative abundance of the genus Bilophila was observed between the water and lemon water groups (decrease in the lemon water group, p = 0.036).
- Marginally significant differences were observed in the genera Adlercreutzia (p = 0.095), Haemophilus (p = 0.076), Megamonas (p = 0.095), and Roseburia (p = 0.065).
[Secondary Outcomes]
Not applicable (None)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044970
