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 (DORA)
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
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Li Bing Tan
- Número de telefone: +6596771523
- E-mail: LiBing.TAN@danone.com
Estude backup de contato
- Nome: Jill Wong
- Número de telefone: +6582281172
- E-mail: Jill.WONG@danone.com
Locais de estudo
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Singapore, Cingapura
- Recrutamento
- Woodland Hospital
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Contato:
- Bryan Tan, MBBS
- Número de telefone: +65 63633000
- E-mail: wh.enquiry@nhghealth.com.sg
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Investigador principal:
- Bryan Tan, MBBS
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Subinvestigador:
- Sharma Dilip, MBBS
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Subinvestigador:
- Shanmugaraja Muthuraju, MBBS
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Enercal complete
- Anlene
- Ensure
- Use of systemic antibiotics within the last 8 weeks prior to screening
- Known allergy or intolerance to Galactooligosaccharides (GOS), lactose, probiotics, or any ingredient in the SP
- Gastrointestinal (GI) surgery within the last 6 months prior to screening
- BMI below 18.5 kg/m² or above 27.5 kg/m²
- Participants who are using insulin, or have poorly controlled diabetes (HbA1c ≥ 10%) within last 3 months prior to screening
- 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
- 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
- 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
- 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
- Participant expected to be living in the same home as a current participating participant and to concomitantly receive SP
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Nutritional intervention
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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in relative abundance of gut microbiome composition
Prazo: Baseline and end of intervention (after at least 28 days of study product consumption)
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Change from baseline in the relative abundance of gut microbiome composition following consumption of the synbiotic nutritional product.
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Baseline and end of intervention (after at least 28 days of study product consumption)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bryan Tan, Woodlands Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 24REX0079694
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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