Tokyo, Nov. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059841) titled 'Investigation of the effect of test food intake on fatigue reduction after exercise load' on Nov. 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Metagen, Inc.

Condition: Condition - Healthy male adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluate the fatigue-reducing effect of oligosaccharide Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consumption of test food for 8 weeks Interventions/Control_2 - Consumption of placebo food for 8 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key 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. Key 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) Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 10 Day Date of IRB - 2025 Year 11 Month 07 Day Anticipated trial start date - 2025 Year 11 Month 27 Day Last follow-up date - 2026 Year 03 Month 21 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068430

Disclaimer: Curated by HT Syndication.