Healthy male adults
Conditions
Interventions
Take two tablets of the test food per day ->
washout ->
Take two tablets of the control food per day
Take two tablets of the control food per day ->
Take two tablets of the test food per day
Sponsors
Metagen, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) At informed consent, male subjects aged more than or equal to 18, and less than 60 years old. (2) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1)Subjects who have a plan or who have taken the food containing quercetin within a month before the trial start or during the trial. (2)Subjects who have a plan or who have taken medication within a month before the pre-test start or during the trial, which would affect the trial result. (3)Subjects who had undergone appendectomy. (4)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (5)Subjects who are expected to undergo major changes in their living environment such as home and work during this trial. (6)Subjects with irregular dietary habits. (7)Subjects who take excessive alcohol. (8)Subjects whose roomer is planning to join this trial. (9)Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within 4 weeks before this trial, or will join those after giving informed consent to participate in this trial. (10)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (11)Subjects who are allergic to medicines and test foods (related to lactic acid bacteria). (12)Subjects who donated their blood components, and/or whole blood 200 mL within a month before the trial start. (13)Subjects who donated their blood components, and/or whole blood 400 mL within 3 months before the trial start. (14)Subjects whose collected blood volume within the last 12 months before the trial start would reach to 1,200 mL after adding the blood collection in this study. (15) Others who have been determined ineligible by the principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodynamic tests (quercetin, quercetin conjugates, quercetin metabolites) | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal microbiota Intestinal metabolites Urinary metabolites (quercetin, quercetin conjugates, quercetin metabolites) Blood inflammatory system test (IL-6, TNF-alpha) Blood nervous system test (serotonin) Salivary stress test (chromogranin A, cortisol) Skin test (stratum corneum water content, transdermal water transpiration, skin viscoelasticity) Defecation status (frequency, number of days, amount, consistency, color, feeling of incomplete evacuation, abdominal pain) Eating habits and lifestyle questionnaire Body composition POMS2 short version abbreviated version - VAS for body sensation | — |
Countries
Japan
Contacts
Public ContactShinnosuke Murakami
Metagen, Inc. Headquarters
Outcome results
None listed