Psychiatric disorders
Conditions
Interventions
Rice, 8 weeks
Grains except rice (however, this shall not be applied for dinner), 8 weeks
Sponsors
Hokkaido Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged equal to or more than 40 years and less than 70 years 2. Healthy males and females without any treatment 3. Subjects who have high score in PSQI-J and have one or more of Metabolic syndrome diagnostic criteria 4. Subjects who regularly take 3 meals a day. 5. Subjects who usually take grains except rice at least 1 meal of 3 meals a day. 6. Subjects who understand the object and contents of the study and submit written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who use drugs of glycometabolism, lipidmetabolism, or reducing high blood pressure 2. Subjects who are treated sleeplessness or sleep disorder 3. Subjects who plan to become pregnant, who are during pregnancy, or who are nursing 4. Subjects who participate in other clinical trials or whose participation finishes within one month prior to the current clinical trial 5. Subjects who have marked impairment of liver, kidney, heart 6. Subject with a history of allergy to medicine and food 7. Subjects who smoke excessively and drink alcohol habitually 8. Subjects whose eating habits are extremely irregular or who are midnight and irregular shift workers 9. Subjects who are ineligible due to physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of the Pittsburgh sleep questionnaire Japanese edition (PSQI-J), at 0, 4 and 8 weeks after test start | — |
Secondary
| Measure | Time frame |
|---|---|
| d-ROM, BAP, BS, HbA1c, GA, Inslin, Waist circumference, TG, HDL-Cholesterol, Blood Pressure, PHQ-9, SF-8, STAI, and metabolites, at 0, 4 and 8 weeks after test start | — |
Countries
Japan
Contacts
Public ContactTomita Shimpei
New drug research center, Inc. Clinical Research Dept.
Outcome results
None listed