None
Conditions
Interventions
Take two capsules (520 mg) of the test food orally at dinner for 12 weeks
Take two capsules (520 mg) of the placebo food orally at dinner for 12 weeks
Sponsors
New drug research center, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged of 20-64 years. 2) Subjects whose BMI values are 23.0 or more and less than 30.0. 3) Subjects who can visit the hospital/clinic on the scheduled visit date 4) Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
Exclusion criteria
Exclusion criteria: 1) Subjects who are under treatment or have a history of serious liver damage/disease, kidney disease, heart disease, lung disease, gastrointestinal disease (including gastrectomy), other severe disorders, or diabetes 2) Subjects who are under treatment (Excluding transient treatment such as common cold) 3) Subjects who cannot maintain their own life-style 4) Subjects who plan to travel overseas or have a long business trip during this study period 5) Subjects who are shift workers or graveyard shift workers 6) Subjects who use oral medication or supplements which may affect this study 7) Subjects drink alcohol over 1,000mL in terms of beer (= 40 mL of pure alcohol) per day 8) Subjects smoke over average 20 cigarettes per day 9) Subjects who are pregnant, lactation, or planning to become pregnant 10) Subjects who are sensitive to test product or other foods, and medical products. 11) Subjects who cannot take the test food as instructed 12) Subjects who donated blood component or more than 200 mL of whole blood from the last one month just before the start of the study 13) Subjects who have experienced sickness due to blood collection 14) Subjects in constipation (frequency of defecation twice or less a week, feces is hard, difficulty of defecation, feeling of remaining feces) 15) Subjects who participated in other clinical studies in the past 3 months 16) Subjects who have some metal inside the body 17) Subjects judged as unsuitable for this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area, body fat mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal subcutaneous fat area, abdominal total fat area, waist circumference, hip circumference, W/H ratio, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, blood pressures (systolic and diastolic), fasting blood glucose, insulin, HbA1c | — |
Countries
Japan
Contacts
Public ContactToyotada Ashino
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed