Healthy male adults
Conditions
Interventions
Consumption of test food for 8 weeks
Consumption of placebo food for 8 weeks
Sponsors
Metagen, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) At informed consent, male subjects aged more than or equal to 20, and less than 65 years old. (2) Subjects who habitually exercise once or twice a week (exercise of 5 METs or more for 30 minutes or more, excluding resistance training). (3) Subjects who can continue their exercise habits from before study participation during the study period. (4) Subjects who can consume coffee daily. (5) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods that may affect the study (fatigue-reducing effect, intestinal regulation, etc.) from the time consent is obtained. (2) Subjects who are unable to discontinue consumption of supplements (including powder, tablets, capsules, and other forms distinct from ordinary foodstuffs, taken for nutritional or functional purposes regardless of ingredients or functionality) from the time consent is obtained. (3) Subjects who have taken drugs (antibiotics, intestinal regulators, laxatives, etc.) that would affect the study one month prior to the pre-test, or those who plan to take them during the study. (4) Subjects with a tendency for constipation (defecation frequency of 5 times or less per week) or a tendency for diarrhea (more than half of weekly defecations are mushy or watery stools) at the background survey. (5) Subjects with a history of appendectomy. (6) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent. (7) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study. (8) Subjects with extremely irregular eating habits or lifestyle rhythms. (9) Subjects whose roommates plan to participate in the study. (10) Subjects who have smoked within the past year. (11) Heavy alcohol drinkers. (12) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (13) Subjects allergic to medicines and foods. (Due to character limitation, the following will be listed in the "Others" section)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation status (presence or absence of defecation, frequency, time of defecation, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor) 2. Gut microbiota 3. Gut metabolomes 4. Abdominal symptoms (bloating, belching, gas(flatus frequency)) at times other than during defecation 5. RPE 6. POMS2 Japanese version, Short Form 7. Blood biochemical parameters (CK, GLU, Lactic acid, Free fatty acids) | — |
Countries
Japan
Contacts
Public ContactFumiko Nakamura
CPCC Company Limited Clinical Support Division
Outcome results
None listed