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

NCT07575529 | Not Yet Recruiting DMC

• 1 other identifier: 24REX0079694
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Adult Participants; Gut Microbiomes; AI

Keywords

Healthy Aging; Gut Microbiome; Gut Health; Probiotics; Prebiotics; Nutritional Intervention; Microbiome Profiling; Digital Health; Wearable Devices

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and end of intervention (after at least 28 days of study product consumption)

Study Arms (1)

Nutritional intervention

EXPERIMENTAL

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

Interventions

Synbiotic Nutritional Product DIETARY_SUPPLEMENT

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.

Nutritional intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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, investigational 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.

You may not qualify if:

• 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:
• BioGaia Probiotic Tablets
• LACTO FIT Probiotics
• Nano Singapore Digestive Wellness Formula
• California Gold Nutrition LactoBif Probiotics
• Life Space Probiotic
• Vivomixx 112.5 Billion Live Probiotics
• Duolac Daily Vitality Probiotic
• ATOMY Probiotics 10+
• Blackmores Ultra Max Probiotics+
• Holistic Way High Strength Probiotic 75 Billion
• 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:
• Boost Optimum

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• Woodlands Health Campus: collaborator

Study Officials

• Bryan Tan

  Woodlands Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Bing Tan

CONTACT

+6596771523; LiBing.TAN@danone.com

Jill Wong

CONTACT

+6582281172; Jill.WONG@danone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory analytical models are used in this study to examine relationships among gut microbiome profiles, stool- and blood-based biological markers, questionnaire-derived measures, and digital health data collected longitudinally in healthy adults. The modeling framework integrates multimodal data sources, including microbiome sequencing outputs and wearable- and sensor-derived physiological parameters, to support descriptive and associative analyses. The study follows a single-arm, open-label interventional model with a baseline observation period prior to initiation of the synbiotic nutritional intervention. This within-participant longitudinal design allows each participant to serve as their own reference, enabling exploratory comparison of post-intervention measures relative to baseline. All models are research-focused and exploratory in nature and are not designed, trained, or validated for diagnostic, prognostic, screening, or clinical decision-making purposes.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share