UMIN-CTR Clinical Trial

Basic information
Public title	Study on the AGEs-reducing effects induced by test food intakes
Acronym	Study on the AGEs-reducing effects induced by test food intakes
Scientific Title	Study on the AGEs-reducing effects induced by test food intakes
Scientific Title:Acronym	Study on the AGEs-reducing effects induced by test food intakes
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate AGEs-reducing effects associated with 12 weeks daily ingestion of the test food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Advanced glycation-end products
Key secondary outcomes	1. Blood sugar level on empty stomach 2. HbA1c 3. Changes in clinical test values

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	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of the test food 1 twice a day for 12 weeks.
Interventions/Control_2	Ingestion of the test food 2 twice a day for 12 weeks.
Interventions/Control_3	Ingestion of the placebo food twice a day for 12 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Males/females ranging in age from 20 to 64 at informed consent. (2) Subjects equipped with no more than 6.4% of HbA1c. (3) Subjects who have no difficulty in ingesting the test food twice a day. (4) Subjects who have no difficulty in receiving the test food twice a week. (5) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects with some kind of continuous medical treatment. (2) Subjects who are now under the restriction of carbohydrate with dieting (losing some weight by exercises and meal-controlling), and/or are planning to go on a diet, during this trial. (3) All through this trial, subjects who have any difficulty in refraining from taking steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods, which might affect the test results. (4) Subjects who are planning to change their lifestyle. (5) Subjects with extremely irregular eating habits. (6) Subjects having not less than once a week , restricting their mealtimes to no more than once a day, within the last three months. (7) Subjects who extremely take alcohol. (8) Pregnant, possibly pregnant, or lactating women. (9) Subjects having present/previous medical history of serious diseases in heart, liver, kidney, and/or digestive organs. (10) Subjects with drug and/or food allergies, especially in wheat, eggs and milk. (11) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within four weeks before this trial, or are planning to participate in those after giving informed consent to take part in this trial. (12) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this trial. (13) Males who donated over 400 mL of their whole blood within the last three months before this trial. (14) Females who donated over 400 mL of their whole blood within the last four months before this trial. (15) Males who will be collected over 1200 mL of their blood within the last twelve months before this trial. (16) Females who will be collected over 800 mL of their blood within the last twelve months before this trial. (17) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
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
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	Nisshin Seifun Group 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	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	2022 Year 01 Month 07 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 12 Month 01 Day
Date of IRB	2020 Year 11 Month 20 Day
Anticipated trial start date	2021 Year 01 Month 07 Day
Last follow-up date	2021 Year 04 Month 25 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 01 Month 05 Day
Last modified on	2021 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048980

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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