Healthy adult
Conditions
Interventions
Intake test food for 4 weeks >
washout for 4 weeks >
Intake placebo for 4 weeks
Intake placebo for 4 weeks >
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy men and women aged between 40 and 59 (2) Subjects who have fully comprehended the purpose and content of this study and provide informed consent to participate voluntarily (3) BMI 25 or more and less than 30 kg/m2 (4) Among subjects who defecation frequency 3 to 5 times a week, select from subjects with high BMI
Exclusion criteria
Exclusion criteria: Subjects(who) (1) regularly consume foods that potentially affect the gut microbiota (2) regularly consume medications or quasi-drug that potentially affect the gut microbiota (3) undergoing treatment for gastrointestinal diseases that could affect this study or those with a history of gastrointestinal surgery (4) diagnosed with or having a history of conditions impacting defecation frequency (5) regularly engage in physical exercise (6) smoke excessively(more than 21 cigarettes a day) (7) regularly consume alcohol(more than 40 grams of pure alcohol a day) (8) are pregnant, breastfeeding, or planning to become pregnant (9) are judged to be inappropriate as subjects by lifestyle questionnaire (10) at risk of allergic reactions related to this study (11) with chronic conditions requiring continuous medication, those undergoing treatment, or those with a history of serious medical conditions requiring medication (12) are judged as inappropriate for this study based on the results of clinical and physical examination on preliminary examination (13) with irregular lifestyle patterns due to shift work, night shifts, etc. (14) undergoing significant lifestyle changes due to moving, traveling abroad, etc. (15) have participated in another clinical study within the past month or are currently participating in another clinical trial at the start of this study (16) are judged as inappropriate by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diversity of the gut microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of the gut microbiota(next generation-targeted amplicon sequencing), fecal metabolites concentration, fecal water content, quantity of functional substance, and subjective evaluation questionnaire(defecation, quality of life, physical conditions) | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
EP Mediate Co., Ltd. R&D Support Center, Foods Department
Outcome results
None listed