UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042907 |
|---|---|
| Receipt number | 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 22:55:09 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048980
