UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045243