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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042907
Receipt No. R000048980
Scientific Title Study on the AGEs-reducing effects induced by test food intakes
Date of disclosure of the study information 2022/01/07
Last modified on 2021/09/14

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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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