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 |
Study on the AGEs-reducing effects induced by test food intakes
Study on the AGEs-reducing effects induced by test food intakes
Study on the AGEs-reducing effects induced by test food intakes
Study on the AGEs-reducing effects induced by test food intakes
Japan |
Healthy male/female adults
Adult |
Others
NO
To investigate AGEs-reducing effects associated with 12 weeks daily ingestion of the test food.
Safety,Efficacy
Exploratory
Pragmatic
Advanced glycation-end products
1. Blood sugar level on empty stomach
2. HbA1c
3. Changes in clinical test values
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
No need to know
3
Prevention
Food |
Ingestion of the test food 1 twice a day for 12 weeks.
Ingestion of the test food 2 twice a day for 12 weeks.
Ingestion of the placebo food twice a day for 12 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(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.
(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.
21
1st name | Suguru |
Middle name | |
Last name | Fujiwara |
CPCC Company Limited
Division of Clinical Research
101-0047
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-3112
cpcc-contact@cpcc.co.jp
1st name | Makoto |
Middle name | |
Last name | Ichinohe |
CPCC Company Limited
Clinical Planning Department
101-0047
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
Nisshin Seifun Group Inc.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
03-5297-5548
IRB@cpcc.co.jp
NO
2022 | Year | 01 | Month | 07 | Day |
Unpublished
Completed
2020 | Year | 12 | Month | 01 | Day |
2020 | Year | 11 | Month | 20 | Day |
2021 | Year | 01 | Month | 07 | Day |
2021 | Year | 04 | Month | 25 | Day |
2021 | Year | 01 | Month | 05 | Day |
2021 | Year | 09 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048980