Healthy adults
Conditions
Interventions
Subjects receive 100 mg/day of Kaempferia parviflora for 12 weeks.
Subjects receive placebo for 12 weeks.
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy subjects who meet all of the following criteria will be included in the study 1) The subject must have received a full explanation of his/her participation in this study, and must have given written consent of his/her own free will based on a thorough understanding of the subject's situation. 2) Healthy men and women who are 45 years of age or older at the time consent is obtained. 3) Those with an MMSE-J score of 24 or higher at screening.
Exclusion criteria
Exclusion criteria: Research subjects who are in conflict with any of the following will not be included in this study 1) Those who consume health foods that may affect clinical research. 2)Those who have been exercising for at least one hour daily for at least six months on a continuous basis. 3)Those who have an irregular rhythm of life due to night shift work, shift work, etc. 4) Those who have extremely irregular eating, sleeping, and other lifestyle habits. 5) Those with color blindness 6) Those with a history of treatment for malignant tumors, heart failure, or myocardial infarction. 7) Persons under treatment for the following chronic diseases Atrial fibrillation, arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases 8)Persons suffering from dementia 9) Persons under treatment for or with a history of psychiatric disorders 10)Persons who regularly use pharmaceuticals (including herbal medicines) 11) Have allergies (to pharmaceuticals or food related to the tested food (squid)) 12)Currently participating in other clinical research or clinical trials, or have participated in other clinical research or clinical trials within the past 3 months. 13)Pregnant, lactating, or intending to become pregnant 14) Other subjects deemed inappropriate for this study by the investigator. Rationale 1) to 5) Influence on efficacy evaluation, 6) to 14) Safety considerations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the cognitive function | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the height, weight, body composition, abdominal circumference, lower leg circumference, grip strength, vision, hearing, muscle strength, gait, blood test, urine test, BDNF, vascular endothelial function test, bone density test, tear fluid volume, saliva volume, skin test, questionnaire We will compare measurements before intake, 6 weeks after intake, and 12 weeks after intake between each group. | — |
Countries
Japan
Contacts
Public ContactMasaki Igarashi
The University of Tokyo Hospital Department of Diabetes and Metabolic Diseases
Outcome results
None listed