DORA - An Exploratory, Interventional Study Using Digital Health Tools and OneBiome to Explore th… (NCT07575529) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
DORA - An Exploratory, Interventional Study Using Digital Health Tools and OneBiome to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
100 participantsStarted 2026-04-27
Plain-language summary
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital health parameters in community-living adults in good health.
The study enrolls adults aged 40 to 65 years and aims to investigate changes in gut microbial composition, with a primary focus on butyrate-producing microbial taxa, following at least 28 days of study product consumption. Secondary and exploratory objectives include assessment of stool metabolites, blood-based biomarkers, bowel patterns, sleep quality, physical activity, cognitive function, dietary patterns, and quality of life.
Approximately 125 participants will be recruited in Singapore to achieve 100 study completers. Following informed consent and screening, participants undergo a baseline observation period of 14 days during which physiological and lifestyle data are collected using wearable digital health devices. Baseline assessments also include blood sampling, stool collection for microbiome analysis, digital imaging and videography, and completion of validated questionnaires.
After completion of baseline assessments and collection of the first stool sample, participants initiate consumption of the study product, a senior milk powder containing a defined synbiotic formulation. The study product is consumed twice daily for a minimum of 28 days and up to 35 days to allow completion of study assessments.
Participants return for end-of-intervention assessments following the study product phase, including repeat biological sampling, physical and digital assessments, and questionnaires. Stool microbiome profiles and other exploratory outcomes are compared between baseline and post-intervention time points.
This exploratory study is intended to generate feasibility data and hypotheses regarding the effects of synbiotic nutritional intervention and the integration of biological and digital health data in the context of healthy aging.
Who can participate
Age range40 Years – 65 Years
SexALL
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Inclusion criteria
✓. Participants aged between 40 to 65 years (bounds included)
✓. Participants who are community-living
✓. Participants who are in good health (self-reported)
✓. Participants own and are willing to use their personal non-shared mobile device (iPhone 8 or later, with iOS version 16 or later), to pair with the study-provided Apple Watch SE, for the duration of the study
✓. Participant should be able to use mobile applications on smartphones to perform tasks in the study, have access to the internet and a smartphone or tablet to take and upload images and/or videos of stool, and other anatomical sites
✓. Participant should be able to comprehend the content of the study and to complete the study questionnaires in English
✓. Written and signed consent from participant
✓. Currently reside in Singapore and with the intention to reside in Singapore for at least the duration of the study.
Exclusion criteria
What they're measuring
1
Change in relative abundance of gut microbiome composition
Timeframe: Baseline and end of intervention (after at least 28 days of study product consumption)
. Pregnant or lactating, or wish to become pregnant during the period of the study (self-reported)
✕. Participant with current or intended participation in a clinical study involving investigational or marketed products
✕. Use of named prebiotics, probiotics or synbiotics (in a capsule or sachet) within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to the products listed below:
✕. Use of any commercial healthy aging milk powder within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to:
✕. Use of systemic antibiotics within the last 8 weeks prior to screening
✕. Known allergy or intolerance to Galactooligosaccharides (GOS), lactose, probiotics, or any ingredient in the SP
✕. Gastrointestinal (GI) surgery within the last 6 months prior to screening