None listed
Conditions
Interventions
12 weeks).
Oral intake of the control food (1 packet in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study. 2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing. 3) Individuals who can come to the designated venue for this study and be inspected. 4) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: 1) Individuals using medical products. 2) Individuals suffering from or undergoing treatment for renal disease, liver disease, cardiac, respiratory, endocrine, or other metabolic diseases, psychiatric disorders, or sleep disorders, as well as individuals with a history of serious illness. 3) Individuals with gastrointestinal diseases affecting digestion and absorption and a history of gastrointestinal surgery (except appendicitis). 4) Individuals who are regular drug users and have a history of taking medication for the purpose of treating a disease in the past month (excluding abrupt medication history such as headache, menstrual cramps, common cold, etc.). 5) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 6) Individuals who experienced unpleasant feeling during blood drawing. 7) Individuals with diarrhea or excessive constipation on a daily basis. 8) Individuals who have difficulty swallowing. 9) Individuals with drug or food allergies. 10) Individuals who are aware of lactose intolerance. 11) Individuals who have a habit of consuming Food for Specified Health Use, Food with Functional Claims, Food with Nutrient Function Claims or Health Foods. 12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 13) Shift workers or night workers 14) Individuals with possible changes of life style during the test period (e.g., work at night, travel for long periods of time, etc.). 15) Individuals who are pregnant, lactating or may become pregnant during the study period 16) Individuals who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 17) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Changes and Variations in Physical Examinations 2) Clinical Laboratory Changes and Variations 3) Doctor's questions 4) Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) 5) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed