UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043275 |
|---|---|
| Receipt number | R000045243 |
| Scientific Title | Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2022/03/08 17:54:45 |
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Basic information
Public title
Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide
Acronym
Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide
Scientific Title
Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide
Scientific Title:Acronym
Functional exploratory trial of symbiotic connection between food microorganism and oligosaccharide
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine some kind of effect on obesity-related indexes for elucidating the symbiotic connection between the food microorganism and oligosaccharide exploratorily, employing eighty healthy little-overweight subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Visceral fat area
2. Body fat percentage
3. Body fat mass
4. Body weight
5. Body mass index
6. Gut microbiota
7. Short chain fatty acids in blood and feces (acetic/propionic/n-butyric/iso-butyric/n-valeric/iso-valeric acids)
8. Gastrointestinal hormones (PYY, GLP-1, GIP, insulin)
9. Blood-biochemical test (Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, blood glucose, and HbA1c)
Key secondary outcomes
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of pro/prebiotics for 12 weeks.
Interventions/Control_2
Oral ingestion of probiotics for 12 weeks.
Interventions/Control_3
Oral ingestion of prebiotics for 12 weeks.
Interventions/Control_4
Oral ingestion of placebo for 12 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male/female subjects ranging in age from 20 to 64 at informed consent.
2) Subjects ranging in BMI from 25.0 to <30.0 kg/m2.
3) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the experimental protocol detail.
Key exclusion criteria
1) Subjects with previous/present medical history of serious diseases.
2) Subjects who contracted a digestive disease within the past two weeks, and are now under medical treatments.
3) Subjects with medical therapies for a lifestyle-related disease, such as diabetes, hypertension and dyslipidemia.
4) Subjects with milk allergy or suspicious one.
5) Pregnant, possibly pregnant during this trial, or lactating women.
6) Subjects falling into the habit of heavy smoking, excessive alcohol intake, and/or an irregular life rhythm.
7) Subjects taking steadily (not less than three times a week) in the health foods, probiotics, prebiotics, fermented milk and/or lactic acid beverages, which might affect the test results.
8) Subjects who took part in the other clinical/monitoring tests, except observing ones, within a month before giving informed consent to take part in this trial.
9) Others who have been determined as ineligible for participation in this trial, judging from the principal/sub investigator's opinions.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
101-0047
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-5548
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045243
