An interventional study of Synbiotic Nutritional Product in Healthy Adult Participants, Gut Microbiomes and AI, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Recruiting at 1 site in Singapore. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Danone Asia Pacific Holdings Pte, Ltd. (part of Danone) · Not applicable, Interventional, and Basic science
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.
Aging is a multifactorial biological process influenced by genetic, metabolic, environmental, and lifestyle factors. Increasing evidence suggests that the gut microbiome plays an important role in healthy aging, with associations reported across metabolic health, immune regulation, inflammatory processes, bowel function, cognition, and overall physiological resilience. Specific gut microbial communities, have been associated with favorable health outcomes and markers of healthy aging.
Synbiotics combine probiotics with complementary prebiotic substrates and are intended to selectively enhance beneficial gut microbial populations. The study product evaluated in the DORA study is a senior milk powder containing a defined synbiotic formulation.
Advances in digital health technologies now enable continuous and remote assessment of physiological, behavioral, and lifestyle parameters in daily living environments. The integration of wearable devices, mobile applications, and biological sampling allows the generation of longitudinal, multidimensional datasets. These approaches support exploratory research into physiological patterns relevant to healthy aging and facilitate investigation of potential digital biomarkers.
The DORA study is designed as an exploratory, single-arm nutritional intervention study to examine the effects of synbiotic consumption on gut microbiome-related outcomes in community-living adults in good health. The primary scientific focus is on gut microbiome composition, especially microbial taxa associated with short-chain fatty acid production. In addition, the study explores relationships between gut microbiome features and a range of biological, physiological, behavioral, and digital health parameters.
Participants undergo a baseline observation phase prior to study product initiation to characterize habitual health patterns and support within-participant comparisons over time. Following the intervention period, post-intervention assessments allow exploratory evaluation of changes relative to baseline. This longitudinal framework is intended to support descriptive and association-based analyses rather than formal hypothesis testing.
Beyond microbiome-related outcomes, the study includes exploratory assessments of stool-derived metabolites, blood-based biological biomarkers, bowel habits, dietary intake, sleep, physical activity, cognition, and quality of life. Digital health tools are used to capture continuous or near-continuous physiological and behavioral data, including activity, sleep patterns, heart rate-related measures, oxygen saturation, respiratory parameters, mobility metrics, and glucose profiles.
An additional exploratory component of the study is the integration of biological, clinical, and digital health data to support development of composite indicators and exploratory analytical models. Image-, video-, and sensor-based data are collected to assess feasibility and accuracy of advanced analytical approaches, including exploratory artificial intelligence methods. These analyses are conducted for research purposes only and are not intended for diagnostic or clinical decision-making.
The DORA study is exploratory in nature and is not designed to establish clinical efficacy, validate diagnostic tools, or demonstrate causal relationships. Findings will be interpreted descriptively, with emphasis on feasibility, data integration, variability, and observed associations. Results are intended to inform hypothesis generation, methodological development, and the design of future studies investigating nutritional strategies and digitally enabled assessment approaches in the context of healthy aging.
Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: Clinical trial participants may be permitted to undertake short-duration travel not exceeding 72 consecutive hours each time, provided such travel does not conflict with scheduled study visits, product administration, or protocol-defined assessments. Prior notification to principal investigator or designated study personnel is required. The participant must be instructed on potential risks, adverse event reporting during the travel period.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm receive the study product, a synbiotic-based senior milk powder, consumed twice daily following a baseline observation period. The study product contains a defined combination of probiotic and prebiotic components and is administered to all participants for the duration of the intervention phase as part of an exploratory nutritional study in healthy adults.
Dietary Supplement: Synbiotic Nutritional Product
Participants receive a nutritional product administered as a senior milk powder. The study product contains a defined combination of probiotic and prebiotic components and is consumed twice daily following a baseline observation period. The intervention is provided to all participants during the intervention phase as part of an exploratory nutrition study in healthy adults. No placebo or comparator intervention is included.
Change in relative abundance of gut microbiome composition
Change from baseline in the relative abundance of gut microbiome composition following consumption of the synbiotic nutritional product.
Time frame: Baseline and end of intervention (after at least 28 days of study product consumption)
Plan to share: No — Individual participant data will not be shared. Data collected in this study will be used solely for the purposes described in the protocol and handled in accordance with applicable data protection regulations and data processing agreements.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Feb 2027, 10 months after the start.
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