Healthy subjects
Conditions
Interventions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Employees working in cooperative company. 2)Subject who can be inspected on the specified inspection date. 3)Subject with a BMI of 23 kg/m2 or more. 4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1)Subject who cannot continue to take the test food due to business trips during the intake period (sbject who is known in advance that the eating rate will be less than 80%). 2)Subject who is taking medication or under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food. 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness (depression) or sleep disturbance. 7)Subject who has irregular work rhythms such as working at night and shift work. 8)Subject who has extremely irregular lifestyle such as eating and sleeping. 9)Subject who has an unbalanced diet. 10)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases (including subject who uses implantable medical electrical equipment such as pacemakers, subject who uses implantable metal medical equipment, and subject who is undergoing artificial dialysis). 11)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 12)Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition. 13))Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14)Subject who can't keep the daily records. 15)Subject who is judged as an inappropriate candidate according to the screening data. 16)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs,Body measurements (weight, BMI),Bone density measurement,Visceral fat measurement,WLQ-J,University of Tokyo 1 item version of presenteeism,Dietary habits awareness survey,Blood biochemistry,Intestinal flora test,Defecation survey. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed