None listed
Conditions
Interventions
Oral intake of the test food A (2 tablets in a day
12 weeks).
Oral intake of the test food B (2 tablets in a day
12 weeks).
Oral intake of the placebo food (2 tablets 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 64 years of age at the time of obtaining consent to participate in the study. 2) Individuals whose BMI is not less than 23.0 kg/m2 and under 30.0 kg/m2. 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) using medical products. 2) who used a drug to treat a disease in the past 1 month. 3) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 4) with co-morbidities and serious history of gastrointestinal conditions. 5) with a history or current history of mental illness, sleep disorders, diabetes, hypertension, dyslipidemia or serious illness. 6) who have metal objects in their bodies that cannot be removed, individuals with cardiac pacemakers. 7) who have had a significant change in body weight within 3 months of the start of the study. 8) who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 9) who may develop allergic symptoms to the tested food, or to any other food or drug. 10) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 11) with possible changes of life style during the test period. 12) who are currently, and within the past 3 months have been, or will be during the study period, taking health food products containing ingredients similar to those in the test food. 13) who are currently, or have been within the past 3 months, habitual consumers of foods for specified health uses, foods with functional claims, and health foods that claim to reduce body fat, and who plan to consume such foods during the study period. 14) who are or are possibly pregnant, or are lactating. 15) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 16) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Fat Assessment Index (Week 0, Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary indexes 1) Indicators related to body fat assessment (1) 2) Body composition measurement (2) 3) Weighing at home (3) 4) Waist circumference and buttock circumference measurements/waist-to-hip ratio (2) 5) brief-type self-administered diet history questionnaire (2) * Safety 1) Blood pressure, pulsation (2) 2) Hematologic test (2) 3) Blood biochemical test (2) 4) Urine analysis (2) 5) Doctor's questions (2) 6) Side effects/ Adverse events(4) 7) Subject's diary(3) (1): Week 0, Week 12 (2): Week 0, Week 6, Week 12 (3): Daily from the start of the study food intake to the end of the study (4): Week 6, Week 12 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed