None listed
Conditions
Interventions
12-week intervention of test substance P
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females aged 20 to 64 years-old. (2)Subjects whose BMI are 18.5 or over and under 30. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: Subjects (who) (1) have a chronic disease and use medications affecting obesity, muscle, glucose and lipid metabolism. (2)contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disorders, blood circulation disorders, and/or metabolic disease, diseases of the locomotive organs). (3)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity during test periods. (4)have physical activity affected, or undergoing or scheduled to undergo treatment for locomotive organs. (5)are not constitutionally suited to the test substance P. (6)can't stop drinking from 2 days before each measurement. (7)are judged as unsuitable for the current study by the investigator ased on the interview and vitals conducted during the screening test. (8)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week. (9)are under treatment for or have a history of drug addiction and/or alcoholism. (10)are shift worker, midnight-shift worker, and/or subjects with extremely irregular dietary or exercise habits. (11)are pregnant or planning to become pregnant or breastfeed during the study period. (12)are participating in or willing to participate in other clinical studies using other foods, drugs, health appliances, or the application of cosmetics. (13)are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight(BMI), and body fat percentage(mass) after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Other indexes related to body composition after 12 weeks | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed