Healthy men/female
Conditions
Interventions
Ingestion of the test food (10 capsules a day) with water to the subjects for 4 weeks.
Ingestion of the placebo food (10 capsules a day) with water to the subjects for 4 weeks.
Ingestion of the placeb
Sponsors
Komazawa Women's University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 50 to 100, at informed consent. (2)Persons who have received a full explanation of the study, understand its contents, and have given their written consent. (3)A person who understands the consent statement and obtains his/her signature
Exclusion criteria
Exclusion criteria: (1)Those who are currently receiving medication or outpatient treatment for various diseases that interfere with their daily life. (2)Those who are currently on a strict exercising or dieting under the supervision of a doctor (3)Subjects who may develop food allergies due to the test food (4)Those who have a current or a history of drug dependence or alcohol dependence (5)Those who are undergoing hospital visits for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or have a history of mental illness in the past (6)Subjects with significantly irregular life rhythms (eating, sleeping, extremely unbalanced diet, etc.) (7)Persons using drugs that affect immune function (8)Those who participated in other clinical trials (research) within 3 months before the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period (9)Those who are at risk of aspiration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation status (the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal swelling) | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical condition(amount of food,sleep,skin,feeling,joint pain,cold hands and feet,swelling) | — |
Countries
Japan
Contacts
Public ContactAtsushi Ohashi
Ebara Foods industry,Inc. Creative Division Research Institute
Outcome results
None listed