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RECRUITING

NCT07575529

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

Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-27

Completion Date

2027-03-31

Last Updated

2026-08-03

Healthy Volunteers

Yes

Conditions

Healthy Adult Participants Gut Microbiomes AI

Interventions

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.

Inclusion Criteria: 1. Participants aged between 40 to 65 years (bounds included) 2. Participants who are community-living 3. Participants who are in good health (self-reported) 4. 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 5. 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 6. Participant should be able to comprehend the content of the study and to complete the study questionnaires in English 7. Written and signed consent from participant 8. 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. Exclusion Criteria: 1. Pregnant or lactating, or wish to become pregnant during the period of the study (self-reported) 2. Participant with current or intended participation in a clinical study involving investigational or marketed products 3. 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 4. 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 * Enercal complete * Anlene * Ensure 5. Use of systemic antibiotics within the last 8 weeks prior to screening 6. Known allergy or intolerance to Galactooligosaccharides (GOS), lactose, probiotics, or any ingredient in the SP 7. Gastrointestinal (GI) surgery within the last 6 months prior to screening 8. BMI below 18.5 kg/m² or above 27.5 kg/m² 9. Participants who are using insulin, or have poorly controlled diabetes (HbA1c ≥ 10%) within last 3 months prior to screening 10. Other severe disease(s) impairing activities of daily living or affecting the ability to complete the study assessments such as malignancy, end stage organ failure, COPD on long-term oxygen therapy, stroke with significantly residual functional weakness, cardiac failure with poor effort tolerance, significant neurological disease such as cognitive impairment from dementia, severe neuromuscular disease like Parkinson's disease, psychiatric disease/disorder, auto-immune disease, allergic conditions requiring chronic systemic medication, other severe GI disease(s) such as Crohn's disease, GI cancer, or ulcerative colitis diagnosed by a physician 11. History of drug abuse (Drug Abuse Screening Test (DAST) score of \>2) or alcohol abuse (Alcohol Use Disorders Identification Test (AUDIT) score of \> 7) within the last 6 months prior to screening 12. Participants on a special diet, e.g., vegan, low-carbohydrate for intentional weight loss, ketogenic, low-FODMAP diet at the screening visit, or plan for such diet during the study duration 13. Employees and/or children/family members or relatives of employees of Danone or the study team members (dependent relationship with study team members) participating sites such as, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention 14. Participant expected to be living in the same home as a current participating participant and to concomitantly receive SP

Locations (1)

Woodland Hospital

Singapore, Singapore