Healthy adults
Conditions
Interventions
3 units of the test food are extracted in at least 1050 ml of water, refrigerated for 2 hours, and consumed before or with meals and snacks. The entire amount daily for 8 weeks
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Japanese females with aged 30 and 60 years at the time of informed consent 2.BMI >=25.0 kg/m^2 3.Body fat percentage >= 30% 4.Able to install a dietary survey app on their smartphone and record meals 5.Able to cooperate with full-body photography and consent to publication in academic presentations and media (including TV, magazines, internet, etc.). (Note: published images will show only from the neck down.) 6.Able to enter electronic diaries via smartphone or PC 7.Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Currently receiving outpatient treatment or medication (including Kampo) for any illness (as-needed use permitted) 2.Currently under dietary or exercise therapy supervised by a physician 3.Current or past history of serious illness 4.Habitually drink three or more cups of black tea per day (>=3 days/week; approx. 350 ml per cup) 5.Underwent or are planning weight loss procedures within the past year 6.Regularly use over-the-counter drugs, quasi-drugs, specified health foods, health foods, or supplements (participation allowed if discontinued after consent and during the study) 7.Current or past drug or food allergies 8.Excessive alcohol consumption (>=40g pure alcohol/day) 9.Excessive smoking (>=21 cigarettes/day) 10.Shift workers with night shifts 11.Planned overseas travel during the study 12.Presence of metal implants due to surgery 13.Use of cardiac pacemaker or other implanted medical devices 14.Claustrophobia 15.Poor health during blood collection 16.Pregnant, breastfeeding, or planning pregnancy during the study 17.Participation in another clinical study within 1 month prior to consent, currently participating, or plans to participate during the study 18.Deemed unsuitable for participation by the principal or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examination: weight, BMI, waist circumference, body fat percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| -Blood tests: blood lipids (triglycerides, HDL-C, LDL-C),liver function(AST, ALT, gamma-GPT, cholinesterase),change in blood glucose -CT scans: abdominal fat area (visceral fat area, subcutaneous fat area, total fat area) -Additional blood tests (hematology, biochemistry) -Physiological tests (blood pressure, pulse) -Incidence of adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed