Healthy adult
Conditions
Interventions
Food1: Once a day, dissolve 6 g of the test meal in about 200 ml of water and take instead of dinner. Food2: Take 3 tablets twice daily in the morning and at night with 100 ml of water.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Females from 20 to 64 years-old with a BMI of 25 or above on the date of consent acquisition. (2) Subjects who with apparently excessive caloric intake. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects who have been diagnosed with severe anemia by the results of screening test. (2) Subjects who regularly take medicines. (3) Subjects who cannot stop taking drugs, supplements, and health foods that may affect obesity, hyperlipidemia, lipid metabolism, etc. during the test period. (4) Subjects who suffers from urgent medical treatment or has serious complications. (5) Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption. (6) Subjects who taking supplements and health foods. (7) Subjects who have allergic to the test food ingredients. (8) Those who are allergic to orange, cashew nut, kiwifruit, sesame, soybean, banana, peach, walnut, apple, yam, almond, wheat, gelatin. (9) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (10) Subjects who has metal in DUAL SCAN measurement site due to surgery etc. (11) Subjects who have implantable medical devices such as cardiac pacemakers or implantable defibrillators. (12) Subjects who cannot stop drinking more than 20g per day equivalent to pure alcohol. (13) Subjects who has a medical history or current medical history of drug dependence or alcohol dependence. (14) Subjects who are shift workers or midnight workers. (15) Those who have been diagnosed with familial hyperlipidemia. (16) Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics. (17) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal Visceral Fat Area | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> 1) Weight (BMI)(Visit date) 2) Weight (From ingestion start date to the day before 12W) 3) Body temperature (From ingestion start date to the day before 12W) 4) SFA, TFA 5) Waist circumference / Hip circumference 6) Body fat percentage, body fat mass, muscle mass 7) Biochemical examination 8) Skin, physical condition and cold questionnaire(VAS) <Safety> 1) Interview 2) Blood pressure/pulse rate 3) Hematology test 4) Biochemical examination 5) Urinalysis 6) Subjective symptoms 7) Adverse events | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed