{"type":"trials","record":{"id":388,"source_id":"clinicaltrials-gov","external_id":"NCT07575529","title":"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","brief_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.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Danone Asia Pacific Holdings Pte, Ltd.","enrollment":100,"countries":["Singapore"],"start_date":"2026-04-27","completion_date":"2027-03-31","last_update_date":"2026-08-03","source_url":"https://clinicaltrials.gov/study/NCT07575529","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:45:03.776617+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"ALL","acronym":"DORA","age_range":"40 Years to 65 Years","comparator":null,"organization":"Danone Asia Pacific Holdings Pte, Ltd.","interventions":["Synbiotic Nutritional Product"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in relative abundance of gut microbiome composition — Baseline and end of intervention (after at least 28 days o…"],"design_description":"NA · SINGLE GROUP · BASIC SCIENCE · NONE","source_has_results":false},"controlled_terms":["Healthy Adult Participants","Gut Microbiomes","AI","Synbiotic Nutritional Product"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: microbiome.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct07575529","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-04-27 to 2027-03-31","comparator":null,"confidence":"structured-source","population":"ALL · 40 Years to 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:05:41.117Z","intervention":["Synbiotic Nutritional Product"],"participants":100,"study_design":"NA · SINGLE GROUP · BASIC SCIENCE · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change in relative abundance of gut microbiome composition — Baseline and end of intervention (after at least 28 days o…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: microbiome.","Abstract contains controlled term: microbiome.","Source terminology contains: microbiome.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Microbiome and dysbiosis","slug":"microbiome-dysbiosis"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/388","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}