healthy humans
Conditions
Interventions
control: product code
P-001 12-wk repeated consumption and 4-wk post treatment observation. Dose of 1 serving per day. Visceral fat area measurement every 4-wk.
Active: product code
S-001 12-wk repeated consumption and 4-wk post treatment observation. Dose of 1 serving per day. Visceral fat area measurement every 4-wk.
Sponsors
Higashi shinjyuku Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,25<=BMI<30 2,visceral fat area=>100cm2 3,30<=Age<65 of healthy men and women 4,provided written informed consent from subjects
Exclusion criteria
Exclusion criteria: 1,liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases 2,surgery or therapy within 2 months before the trial 3,medicine user for hyperglycaemia, lipidemia, or hypertension 4,user of supplements or foods with health claim, 5,unpleasant feeling during blood drawing 6,donated 200 mL or more blood within 1 month before the trial 7,skin disease, metal allergy and implanted pacemaker 8,remain constipated 5 days and more 9,changes in weight of 2kg or more within 3 month before the study 10,shift worker 11,business trip and travel planned for 10 consecutive days or more 12,allergies against any constituents in the test diet 13,other clinical study or who intended to participate in one during the study period 14,disagree with explanation for study 15,judged to be inappropriate as subject by physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visceral fat area | — |
Countries
Japan
Contacts
Public ContactShimpei Tomita
New Drug Research Center, Inc. Research Division
Outcome results
None listed