Clinical trial Recruiting at 1 site Interventional Ages 40 to 65

Synbiotic senior milk powder to test gut health and wellness in healthy adults

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

Run by Danone Asia Pacific Holdings Pte, Ltd. · NCT07575529 · Data updated 2026-11-12

This study tests whether a synbiotic senior milk powder changes gut microbiome and health-related measures in healthy adults aged 40–65.

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Quick facts

Study typeInterventional
Ages40 Years to 65 Years
SexAll
Enrollment100 (estimated)
SponsorDanone Asia Pacific Holdings Pte, Ltd.
Industry-sponsored
Locations1 site (Singapore)
StatusRecruiting
StartedApril 27, 2026
Main results expectedFebruary 28, 2027
Study endsMarch 31, 2027
Registry record updatedAugust 3, 2026
Trial IDNCT07575529 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 40–65 in Singapore who are in good health and willing to use a personal mobile device and study wearables.

Probably not a fit

Individuals with significant health issues or those not meeting device requirements may not experience measurable benefits.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label study evaluating a synbiotic-containing senior milk powder in community-dwelling adults in good health. Participants take the product for at least 28 days, with baseline observation over 14 days and continuous digital health monitoring. The primary outcome focuses on gut microbiome changes, especially butyrate-producing taxa, while secondary outcomes include stool metabolites, blood biomarkers, bowel habits, sleep, activity, cognition, diet, and quality of life. Digital health tools and wearables enable longitudinal, remote data collection to explore potential links between the synbiotic intervention and aging-related biomarkers.

Why it matters

Potential benefit: If successful, the product could support gut health and related physiological parameters in aging adults.

How similar studies have gone: Previous work on synbiotics and gut microbiome shows potential benefits, but this exact approach in healthy aging adults with this product is exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Woodland Hospital
    Singapore, Singapore
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.