Healthy participants
Conditions
Interventions
[1] Oral ingestion of a test food (once) [2] Observation [3] Wash-out (2 weeks) [4] Oral ingestion of a placebo food (once) [5] Observation
[1] Oral ingestion of a placebo food (once) [2] Observa
Sponsors
DRC Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Those who have a high blood glucose level at screening test. [2] Those who can give their consent to participate in the study voluntarily in writing.
Exclusion criteria
Exclusion criteria: [1] Those who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study. [2] Those who have changed their habitats to take supplements within past 4 weeks. [3] Those who work in night shift or in day and night shift. [4] Those who have been treated their illness or prevention in a clinic at their informed consent. [5] Those with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, or immune system of the nervous system. [6] Those with the medical histories of alcoholism or drug dependence. [7] Those who might be developed allergic reaction to foods (especially citrus fruits). [8] Those who donated blood over 200mL in the past 4 weeks or over 400mL in the past 12 weeks [men] or 16 weeks [women]. [9] Those who have experience of worsening physical condition due to blood sampling or have been pointed out the blood sampling difficulty due to narrow blood vessels. [10] Those who routinely use or cannot refrain from using health food, supplements, and medications that claim to contain dietary fiber. [11] Those with serious anemia. [12] Those who are pregnant, breast-feeding, or hope to be pregnant during the study period. [13] Those who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) in the past 4 weeks. [14] Those who will not be judged suitable to the participants by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary glucose by 24 hours pooled urine | — |
Secondary
| Measure | Time frame |
|---|---|
| The following index in the OGTT test [1] plasma intact incretin (GLP-1 and GIP) levels [2] Incremental area under the curve of blood insulin [3] Maximum blood insulin level [4] HOMA-beta [5] Incremental area under the curve of blood glucose [6] Maximum blood glucose level | — |
Countries
Japan
Contacts
Public ContactKazumi Naganuma
DRC Co., Ltd. Product Testing Department
Outcome results
None listed