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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044381
Receipt No. R000050699
Scientific Title Verification of the effects induced by test-food intakes on gut microenvironment and IgA
Date of disclosure of the study information 2021/06/02
Last modified on 2021/05/31

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Basic information
Public title Verification of the effects induced by test-food intakes on gut microenvironment and IgA
Acronym Verification of the effects induced by test-food intakes on gut microenvironment and IgA
Scientific Title Verification of the effects induced by test-food intakes on gut microenvironment and IgA
Scientific Title:Acronym Verification of the effects induced by test-food intakes on gut microenvironment and IgA
Region
Japan

Condition
Condition Healthy male/female adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate some kind of effect on gut microenvironment and fecal IgA, by the test-food ingestion for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fecal IgA level
Key secondary outcomes 1. Gut microbiota
2. Gut metabolites
3. Nonspecific serum IgE
4. Food frequency questionnaire (short version of FFQ)
5. Body composition (body weight, internal water content, muscle mass, protein content, mineral content, body fat quantity, body fat percentage, skeletal muscle mass, basal metabolic rate, body mass index, InBody score, abdominal circumference, bone mineral content)
6. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
7. Changes in clinical examination value
8. Constipation assessment scale-mid term

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 Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of the test food (50.0 g) with milk (200 mL) to the subject every morning, for 4 weeks.
Interventions/Control_2 Ingestion of the placebo food (57.3 g) with milk (200 mL) to the subject every morning, for 4 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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria (1)At informed consent, male/female subjects aged more than or equal to 20, and less than 60.
(2)Subjects who get into a habit of having breakfast, and will be able to replace their breakfast by the test food.
(3)Subjects who have a bowel evacuation for 3 to 7 times in a week.
(4)Subjects who show understanding of the study procedures and agreement with participating in the study, by written informed consent prior to the study.
Key exclusion criteria (1)Subjects who take cereal more than 3 times a week.
(2)Subjects who have a plan or who have taken medication within a month before the trial start, which would affect the trial result.
(3)Subjects who are regularly consuming food for specified health uses, food with function claims, supplement and/or health foods which would affects the trial results for more than 3 times a week.
(4)Subjects who cannot drink milk.
(5)Subjects with lactose intolerance.
(6)Subjects who had undergone appendectomy.
(7)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(8)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(9)Subjects who are suspected of seriously chronic/acute infectious diseases.
(10)Subjects who are planning to receive vaccination during this trial.
(11)Pregnant, possibly pregnant, or lactating women.
(12)Subjects who take excessive alcohol.
(13)Subjects with smoking habit, now and/or within a year before this trial.
(14)Subjects with irregular dietary habits.
(15)Subjects whose roomer is planning to join this trial.
(16)Subjects who are planning to change their life style considerably during this trial.
(17)Subjects who have food allergies.
(18)Subjects who are now under the other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial.
(19-21)Subjects who donated their blood components and/or whole blood as below
- all subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months to this trial.
(22-23)Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study;
- males: 1,200 mL
- females: 800 mL
(24)Others who have been determined ineligible by principal/sub investigator.
Target sample size 68

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Fukuda
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code 997-0052
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email research@metagen.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 , Japan
TEL +81-3-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Calbee, Inc.
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 +81-3-5297-5548
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 06 Month 02 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 21 Day
Date of IRB
2021 Year 04 Month 16 Day
Anticipated trial start date
2021 Year 06 Month 02 Day
Last follow-up date
2021 Year 08 Month 05 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 05 Month 31 Day
Last modified on
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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