2.4. Test Design
fatigue
EVENT
Tests were conducted as part of a randomized, double-blind, placebo-controlled, parallel-group study. The study food allocation manager assigned subjects via stratified randomization to three test food intake groups and one control food group. The stratification factors were age, sex, and blood albumin levels. The test food allocation manager kept the study food allocation list strictly confidential until key opening, and blinding was maintained for all parties, except the study food allocation manager.During the study period, subjects were instructed as follows. (1) Refrain from excessive exercise (except for the exercise intervention described below) and maintain a normal lifestyle. (2) Ensure non-routine household chores that require physical effort (e.g., major cleaning, redecorating/repairing the house, shoveling snow, and so on) are limited to once a week. In addition, when household chores that fell under the above categories are performed, record the details on the daily lifestyle survey form. (3) Limit day outings for recreation to twice a month, and limit consecutive outings involving overnight stays to 3 days or less and once a month. In the event that leisure activities that fall under the above categories are undertaken, or in the event that the number of outings exceeds the stipulated number of days for unavoidable reasons, record the details on the lifestyle survey form. (4) Maintain the usual lifestyle and environment (such as eating, drinking, sleeping, working, and so on, other than the aforementioned test meals prior to participation in the study) as much as possible. (5) Do not take any medicines, supplements, or health foods that may affect muscle mass/muscle strength, walking function, or fatigue reduction. If such a ingestion was unavoidable, contact the consultation desk in advance if possible. If ingested, record the details on the lifestyle survey form. (6) During the study period, record the regular intake of unrestricted medicines, supplements, or health foods on the lifestyle survey form, and continue the habit. If you are not currently taking these additional substances, refrain from intaking them for the study period. However, if this becomes unavoidable, notify the consultation desk in advance if possible. (7) During the study period, do not consume health oils (coconut oil, MCT oil, and so on) that could possibly enhance the dietary components that are to be evaluated. (8) During the study period, dairy products could be consumed as long as the amount and frequency remained as usual. In the unlikely event of a change, record the details on the lifestyle survey form. (9) During the study period, do not to participate in any other clinical trials. (10) Do not donate blood or blood products during the study period. (11) If you wish to receive immunizations, health checkups, or physical examinations during the study period, report this in advance to the consultation desk and record it on the lifestyle survey form.