Study design and participants
renal dysfunction, heart disease
LACTOSE INTOLERANCE, CEREBROVASCULAR DISEASE, HEART DISEASE
The protocol was registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN000044896; registered on 18/7/2021). This 8-week randomized controlled trial was conducted at the University of Tsukuba, Japan, between July and October 2021. The intervention period (8 weeks) was determined based on our previous studies that examined the combined effects of LTP ingestion and aerobic exerciseThe inclusion criteria were as follows: (1) age ≥ 45 years, (2) not restricted by a doctor from exercising, (3) not performing moderate- to vigorous-intensity aerobic training, (4) not participating in another clinical trial within 1 year, (5) not having lactose intolerance, (6) agreeing with the contents of the study, and (7) not taking angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker. The exclusion criteria were as follows: (1) care-dependent or support-dependent on the Japanese long-term care insurance system; (2) presence of severe heart disease, cerebrovascular disease, and renal dysfunction; (3) the patient’s medical doctor did not agree to their participation in the study; and (4) limited mobility. In total, 109 participants were contacted to participate in the study. Among them, 20 participants did not provide informed consent, and 11 were taking angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. Therefore, 78 middle-aged and older adults were enrolled in this interventional study (Fig. Flow diagram of the participant’s progress through the 8-week randomized trial. This study was approved by the Ethics Committee of the University of Tsukuba, institute of Health and Sports Sciences (approval no. Tai 020-168). The study conformed to the principles outlined in the Declaration of Helsinki and all participants provided written informed consent.