DORA Study on Effects of Synbiotic Senior Milk Powder on Gut Microbiome and Health in Adults Aged 40 to 65

What this Trial Is About

The DORA study is an exploratory, single-arm clinical trial designed to examine the effects of a synbiotic-containing senior milk powder on the gut microbiome and related health parameters in adults aged 40 to 65 years who are in good health and living in the community. The study aims to investigate changes in gut microbial composition, focusing on butyrate-producing bacteria, alongside assessments of stool metabolites, blood biomarkers, bowel habits, sleep quality, physical activity, cognitive function, dietary patterns, and quality of life. This research integrates biological, physiological, behavioral, and digital health data using wearable devices and mobile applications to explore factors relevant to healthy aging. Participants first complete a 14-day baseline observation period where physiological and lifestyle data are collected via wearable devices alongside biological samples such as blood and stool, digital imaging, videography, and questionnaires. Following this, all participants consume the study product, a senior milk powder containing a defined synbiotic formulation, twice daily for at least 28 days and up to 35 days. After the intervention, participants undergo repeat assessments including biological sampling, physical and digital evaluations, and questionnaires to compare changes from baseline. Throughout the study, participants use personal mobile devices paired with study-provided Apple Watch SE to continuously collect data on activity, sleep, heart rate, oxygen levels, respiratory measures, mobility, and glucose profiles. The study team measures the primary outcome by assessing changes in gut microbiome composition before and after the intervention. The study also monitors exploratory outcomes such as stool metabolites, blood biomarkers, and quality of life factors. This research is intended to generate feasibility data and hypotheses to support future studies on nutrition and digital health in healthy aging.

DORA - A Study Using Digital Health Tools/Platform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals