None listed
Conditions
Interventions
Daily intake one packet (1g) of test food for 12 weeks
Daily intake one packet (1g) of placebo (control food) for 12 weeks
Sponsors
Meiji Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged more than or equal to 18, and less than 65 when obtaining the consent 2. Subjects whose BMI is 25 or more in the screening 3. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who have been reported to have galactosemia 2. Subjects who have history of gastrointestinal surgical procedures or who have undergone endoscopic removal of polyps within one year prior to obtaining the informed consent 3. Subjects who take food or supplement which have the possibility to affect the results of the present study more than 4 days a week before 1 months of informed consent 4. Subjects who can't restrict food or supplement which have the possibility to affect the results of the present study from the observation period to the present study period 5. Subjects who take medications that may affect bowel symptoms or non-steroidal anti-inflammatory drugs such as aspirin more than 3 days a week before 1 months of informed consent 6. Subjects who have taken antibiotics before 2 months of informed consent 7. Subjects who can't restrict taking OTC drugs, quasi-drugs, supplements, or health foods from the day before the examination until the completion of the examination 8. Subjects who are expected to undergo a major change in their home, work, or other living environment during the research period and who have difficulty participating in or continuing research 9. Subjects who are smokers 10. Subjects who have abdominal symptoms by ingesting dairy products 11. Subjects with food allergies 12. Subjects who are pregnant or lactating, or intending to become pregnant during the study 13. Subjects who had participated in other clinical trials within the past month 14. Subjects suffering from or undergoing treatment for diabetes, digestive diseases, heart disease, thyroid disease, adrenal disease, and other metabolic diseases 15. Subjects who tested positive for hepatitis B virus or hepatitis C virus in the screening 16. Subjects deemed unsuitable for the present study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal barrier indexes of urine, blood, and feces | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status, Inflammation markers, Clinical laboratory values, Fecal examination, Izumo scale, POMS2 short version, SF-36v2 acute version, OSA-MA | — |
Countries
Japan
Contacts
Public ContactToshihiro Sashihara
Meiji Holdings Co., Ltd. Wellness Science Labs
Outcome results
None listed