Healthy subjects
Conditions
Interventions
Long-term (24-week) administration of the foods containing spearmint extract
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age:20 years and over, under 65 years old 2)Gender:Japanese males and females 3)Persons eating three meals a day
Exclusion criteria
Exclusion criteria: 1)Persons currently receiving any medication or outpatient treatment 2)Persons with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological and metabolic diseases or complications 3)Persons with a history of drug or food allergy 4)Currently, supplements containing polyphenols (Ginkgo biloba extract, bilberry extract, blueberry extract, cassis extract, acai extract, maxiberry extract, catechin, theaflavine, coconut extract, grape and stem extract, melin jo extract, propolis, turmeric extract, rosemary extract, lemonberm extract, lavender extract, time extract, and sito extract) are taken, and people who are unable to discontinue or plan to drink the supplement by 15 days prior to the start of spearmint extract 5)Patients who are unable to discontinue taking supplements containing rosmarinic acid as the main ingredient (lemonbalm, rosemary, peppermint, perilla, etc.) 6)Individuals with extreme predation 7)Extremely irregular lifestyle, such as eating or sleeping 8)Persons with sleep disorders (e.g., insomnia, sleep apnea syndrome) 9)Persons with a current or past history of psychiatric disorders (e.g., depression) 10)Persons with a current or past history of alcoholism 11)Subjects who are currently participating in other clinical studies or have participated in other clinical studies within the past 3 months 12)Persons with irregular working hours, such as night shifts 13)Other subjects who are considered inappropriate for inclusion in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematology, clinical chemistry profile, systolic blood pressure, diastolic blood pressure, pulse rate, BMI, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed