None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 20-64 years. [2]Subjects who are healthy and have no chronic physical disease. [3]Subjects with LDL cholesterol in the range 120-139 mg/dL. [4]Subjects whose written informed consent has been obtained after explanation of this study. [5]Subjects who can have an examination on a designated check day. [6]Subjects who are judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Subjects using medicines [2]Subjects who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia [3]Subjects who have a history of disease of liver, kidney, heart, lung, and blood [4]Subjects having digestive disease [5]Subjects who fall any criteria when using Fitbit [6]Subjects having drugs within 3 months [7]Subjects having allergies to foods and medicines [8]Subjects whose BMI is over 30 kg/m2 [9]Subjects who donated blood over 200 mL in the past 1 month or over 400 mL in the past 3 months [10]Subjects who continuously intake of functional foods, health foods, supplements, and beverages [11]Heavy drinker (over 40 g/day) [12]Subjects who cannot use application or smartphone for administrating the data of Fitbit [13]Subjects who cannot always ware Fitbit [14]Subjects with changing lifestyle [15]Shift worker or night worker [16]Pregnant, possible pregnant, or lactating [17]Subjects who participated in the other clinical studies in the past 3 months. [18]Subjects who work for a company that commodify health and functional foods by the subjects or his family [19]Subjects who are judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol (Week 0, Week 6 and Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1] Indexes for lipid metabolism(1) [2] Quality of life related research using Fitbit(2) [3] Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ)(1) [4] Questionnaire survey on QOL(1) *Safety [1] Blood pressure, pulsation (1) [2] Weight, body fat percentage, BMI (1) [3] Hematologic test (1) [4] Blood biochemical test (1) [5] Urine analysis (1) [6] Subject's diary (2) [7] Doctor's questions (1) [8] Adverse events: number of cases and expression rate of adverse events (3) (1): Week 0, Week 6 and Week 12 (2): Daily for Week 0 to Week 12 (3): Week 6 and Week 12 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed