Healthy male/female adults
Conditions
Interventions
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.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Advanced glycation-end products | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood sugar level on empty stomach 2. HbA1c 3. Changes in clinical test values | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed