Healthy adults
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy subjects aged of 20-64 years (2) Subjects with BMI >=25 and < 30 in primary 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 in the study based on good understanding, and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: (1) Subjects who take medicines regularly (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 |
|---|---|
| The measured value of abdominal visceral fat area at 12 weeks after ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The measured value of abdominal visceral fat area at 8 weeks after ingestion 2) The amount of change in abdominal visceral fat area (8, 12 weeks after ingestion) 3) The measured value and the amount of change in abdominal subcutaneous fat area (8, 12 weeks after ingestion) 4) The measured value and the amount of change in total abdominal fat area (8, 12 weeks after ingestion) 5) The measured value and the amount of change in body fat percentage (4, 8, 12 weeks after ingestion) 6) The measured value and the amount of change in muscle mass (4, 8, 12 weeks after ingestion) 7) The measured value and the amount of change in body weight and/or body mass index (BMI) (4, 8, 12 weeks after ingestion) 8) The measured value and the amount of change in waist circumference (4, 8, 12 weeks after ingestion) 9) The measured value and the amount of change in hip circumference (4, 8, 12 weeks after ingestion) 10)The measured value and the amount of change in thigh circumference (4, 8, 12 weeks after ingestion) 11)The measured value and the amount of change in upper arm circumference (4, 8, 12 weeks after ingestion) 12)The measured value and the amount of change in the questionnaire on effectiveness (4, 8, 12 weeks after ingestion) | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed