4. Discussion
SECONDARY
In the present study, we showed that our novel 12-week program, a combination of exercise and meal replacement with the “COMB-FP meal” (two meals per day), improved multiple outcomes related to frailty. Significant improvement in both functional ability and cognitive function was the unique effect of our intervention. Although our trial compared an exercise intervention to an exercise and dietary intervention, the importance of daily diet quality was emphasized.Regarding the nutrients for frailty prevention, the importance of energy intake, protein, and micronutrients such as vitamins and omega-3 fatty acids was discussed [Some trials have verified the preventive effect associated with including only a few kinds of nutrients, such as micronutrients, on frailty prevention. Orkaby reported that intervention with vitamin DAs reported by Jennings, the Mediterranean diet with vitamin D supplementation could not improve bone mineral density (BMD) [As described in the Introduction, the Mediterranean diet might be one of the most studied whole dietary replacements for frailty, and the “Nu-age trial” might be the epoch-making study. As reported by Marseglia, one of the most popular results of this study is that cognitive function was not significantly improved by the Mediterranean diet with vitamin D supplementation [As described in the Results, significant differences were not observed in the secondary outcomes. In addition, we plotted the relationship between the amount of energy or protein intake before the intervention and changes in the Kihon Checklist, representing the frailty after the intervention. However, as shown in The “Nu-age trial” reported that continuous consumption of the Mediterranean diet changed microbiota and altered metabolism, including short-chain fatty acids [The WHO-5, known as the well-being index, was developed by the World Health Organization and comprises five questions [Our study had six limitations. First, we could not clarify whether the functional substance contributed to the detected outcomes. We believe that an overall nutritionally balanced diet with adequate calories led to this improved outcome. However, further basic research is required to determine the key substances responsible for changes in outcomes. Second, we tested only Japanese participants. The Mediterranean diet has been tested on Westerners, and it remains to be verified whether this diet, as shown in 