2.2. Study Popuration
dysphagia, dementia, cognitive impairment, allergies
DYSPHAGIA, DIGESTIVE DISORDER, DYSFUNCTION, ALLERGIES
Residents from the suburbs were recruited to participate in this study through a registered monitor, administered by L-Smile Corporation from 11 to 29 November 2021. Interested participants were invited to the designated conference room (Tokyo, Japan). The details of the study and potential risks were explained, and written informed consent was obtained.The inclusion criteria of this trial were as follows:Males and females aged 60 years and above.Individuals who were classified as having pre-frailty or frailty according to the revised Japanese version of the Cardiovascular Health Study (J-CHS) standards.Individuals with a cognitive function test result ranging from normal to mild cognitive impairment (MCI).Individuals who could take a test meal twice a dayIndividuals who had received a full COVID-19 vaccination (took second shots and/or booster shots).Individuals who could provide a sufficient explanation of the purpose and content of the research, have the ability to provide consent, demonstrate a proper understanding of the subject, voluntarily apply for participation, and agree to participate in writing.The exclusion criteria were as follows:
Individuals who planned to donate blood during the trial or donated within the past four weeks.Individuals at risk of developing allergies due to test meals.Individuals with implantable medical electrical equipment, such as pacemakers or other metal medical equipment, or the absence of limbsIndividuals requiring care, the presence of motor dysfunction, dementia, and an inability to perform the exercise program.Individuals with a history of gastrointestinal surgery or a severe digestive disorder.Individuals judged to be extremely picky eaters and have dysphagia or a small appetite.Individuals with extremely irregular eating habits.Individuals with a history of regular intake of protein supplements.Individuals undergoing exercise therapy or diet therapy.Individuals with excessive alcohol consumption (60 g/day) or heavy smoking (21 cigarettes/day).Individuals with irregular daily routines owing to night work or working shifts.Individuals consuming of foods for specific health issues, functional foods, and supplements that would affect the trial.Individuals without a microwave oven.Individuals deemed ineligible for participation by the principal investigator based on blood test results.Participation in other research that involves the consumption of other test foods or the use of pharmaceuticals and cosmetics within one month of providing informed consent or showing willingness to participate.Individuals judged ineligible by the principal investigator.