Healthy adults
Conditions
Interventions
Consumption of the test food (1 pack a day, 12 weeks)
Consumption of the placebo food (1 pack a day, 12 weeks)
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged of 20-64 years 2) Subjects whose BMI is 25 kg/m2 or more and less than 30 kg/m2 at first screening test 3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate on good understanding, and have agreed to participate in the study in writing
Exclusion criteria
Exclusion criteria: 1) Subjects who use habitually medications (including intestinal regulators and laxatives. However, subjects who can stop taking intestinal regulators from the first screening test until the end of this study are permitted.) 2) Subjects who have a current history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease (excluding transient treatment such as colds) 3) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis) 4) Subjects who have a history or current medical history of drug dependence or alcoholism 5) Subjects who have been diagnosed with familial hyperlipidemia 6) Subjects who are diagnosed with chronic constipation 7) Subjects who are unable to stop taking health foods and supplements (including foods for specified health uses and foods with functional claims) that may affect this study 8) Subjects who have a habit of drinking excessively (drinking more than 20 g of pure alcohol equivalent per day, at least 4 days a week) 9) Subjects who have a habit of smoking excessively (smokers of 21 cigarettes or more per day) 10) Subjects who are wearing a medical device necessary for life support, such as a cardiac pacemaker, implantable cardioverter defibrillator, or biological information monitor 11) Subjects who have a contagious disease or an injury to the palms or the soles of the feet 12) Subjects who have metal in the CT scan measurement site due to surgery, etc. 13) Subjects who are claustrophobic 14) Subjects who have reported that they are allergic to the ingredient in test foods 15) Subjects who have extremely irregular eating habits, shift workers (excluding daytime shift work), or late-night workers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change of abdominal visceral fat area at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area Abdominal subcutaneous fat area Abdominal total fat area Body weight Body Mass Index (BMI) Body fat percentage Body fat amount Lean mass Muscle mass Waist circumference Waist-to-Hip ratio | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed