Healthy male/female adults
Conditions
Interventions
Consumption of the test food (1 package) with water (150 mL) to the subjects.
Consumption of the placebo food (1 package) with water (150 mL) to the subjects.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 20 to 64 at informed consent. (2) Subjects having less than 126 mg/dL of blood-sugar level on an empty stomach, and less than 200 mg/dL of the level at the time point of 2 hrs. after a carbohydrate tolerance. (3) 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 who take steadily in the health-specific/functional/supplementary/health foods which might affect this trial, and have any difficulty in giving up taking them during this trial. (2) Subjects who take steadily in the medicines and herbal ones which might affect this trial, and have any difficulty in giving up taking them during this trial. (3) Subjects having not less than 30.0 kg/m2 of BMI. (4) Subjects with excessive alcohol intake. (5) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (6) Pregnant, possibly pregnant, and lactating women. (7) Subjects having drug and/or food allergy (especially in milk). (8) Subjects who are under other clinical trials with some kind of medicine/food, or participated in those within the last four weeks before this trial, or are planning to join those after the consent. (9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (10) Males who donated their whole blood (400 mL) within the last three months to this trial. (11) Females who donated their whole blood (400 mL) within the last four months to this trial. (12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood glucose concentration-time curve | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postprandial blood-sugar level 2. Blood-sugar level (Cmax) 3. Blood-sugar level (Tmax) 4. Insulin level | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed