None listed
Conditions
Interventions
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 with LDL cholesterol in the borderline (120 mg/dL to 139 mg/dL) or mild range (140 to 159 mg/dL). 3) 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. 4) Individuals who can come to the designated venue for this study and be inspected.
Exclusion criteria
Exclusion criteria: Individuals 1) with chronic diseases and individuals undergoing treatment for any disease 2) with a history or current medical history of chronic fatigue syndrome, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases. 3) with a history or current medical history of serious diseases of the liver, kidney, heart, lung, blood, digestive tract, etc. 4) with serious anemia. 5) who have a habit of taking or applying medication for the purpose of disease treatment in the past month. 6) whose BMI is over 30 kg/m2. 7) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug. 8) who are currently, or have been within the past 3 months, habitually consuming or will consume during the study period foods, foods for specified health uses, foods with functional claims, health foods, supplements, etc. that contain a large amount of ingredients similar to those in the test foods. 9) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent. 10) who are a smoker. 11) who work in shifts, work at night, or otherwise have irregular lifestyles. 12) with possible changes of life style during the test period (e.g., work at night, travel for long periods of time, etc.). 13) who have had more than 200 mL of blood drawn (e.g., blood donation) within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study. 14) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 15) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 16) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Exploratory endpoints 1) Lipid-related indicators(1) 2) Additional Exploratory Indicators(1) 3) Physical examination(1) 4) Clinical examination(1) 5) Eating Tendency Survey(1) * Safety endpoints 1) Doctor's questions(1) 2) Side effects/ Adverse events(2) 3) Subject's diary(3) (1):Week 0, Week 6, Week 12 (2):Week 6, Week 12 (3):From the first day of ingestion of a test material to the last day of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed