None listed
Conditions
Interventions
Consumption of test foods for 12 weeks
Placebo (control food) for 12 weeks
Sponsors
Clinical Creative Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age: Men and women between 20 and 80 years old (at the time of obtaining consent) who are able to go to the hospital. (2) Normal subjects (Normal subjects in this study are defined as those who do not have any serious organ disorder or specific disease and are not receiving any treatment related to them or any drug therapy. Whether or not a person is classified as healthy is based on the person's declaration at the start of the study). (3) A person who is able to consume the test food for 12 weeks (4) Those who do not plan to change their daily habits during the examination period. (5) Persons who give written consent (6) Persons who do not meet the following study participant exclusion criteria
Exclusion criteria
Exclusion criteria: (1)Those with a history of treatment for heart failure, myocardial infarction, etc. (2)Exclusion due to disease, etc. (those under treatment for atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic disease, etc.) (3) Those who fall under the judgment criteria D (medical care required) of the Society of Physical Checkups. However, this does not apply to those who are judged by the physician to be within the normal error range. (4) Those who regularly use pharmaceuticals (including herbal medicines), supplements, foods for specified health use, foods with functional claims, and other foods and beverages with possible functional properties. (5)Those who have allergies (to pharmaceuticals or foods related to tested products) (6) Pregnant, lactating, or likely to become pregnant during the study period (7) who have participated or are currently participating in other clinical trials within one month (8) Other subjects who are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation of the recommended intake of 50 mg sugar derivative material at five times the recommended intake of 250 mg sugar derivative material. | — |
Countries
Japan
Contacts
Public ContactRyosuke Kataoka
Clinical Creative Corporation Pharmaceuticals Division
Outcome results
None listed