Grape Impact on Human Gut Microbiome
27 de agosto de 2026 actualizado por: Gang Fang, Icahn School of Medicine at Mount Sinai
High-Resolution Assessment of California Table Grape Consumption on the Human Gut Microbiome-Immune Axis
This is a bio-specimen analysis and dietary intervention study that will examine whether the daily consumption of California table grape powder significantly modulates the gut microbiome and systemic immune profiles in healthy adults.
The primary objective is to characterize longitudinal changes in microbial strains, metabolites, and immune markers following a 4-week grape intervention compared to a placebo.
Methods include a screening of up to 300 individuals to evaluate pre-specified microbiome eligibility criteria, followed by a randomized, double-blind, placebo-controlled, parallel-group design where up to 40 participants will provide fecal and blood samples for high-resolution metagenomic sequencing and LC-MS/MS metabolomics at baseline, mid-study, and post-washout.
Participants who meet the microbiome screening and other study eligibility criteria may be invited to participate in the intervention phase; participation in the screening phase does not guarantee enrollment in the intervention phase.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The human gut microbiome consists of trillions of microorganisms that are essential to host metabolism, immune system regulation, and the maintenance of disease resistance. Recent findings indicate that dietary changes can rapidly and significantly alter the composition of these microbial communities, leading to substantial effects on the host's overall physiology. Foods rich in polyphenols are highly effective at modulating this environment because they possess selective antimicrobial properties and exert beneficial prebiotic effects on the resident microbiota.
Polyphenol-rich foods beneficially modulate the human gut microbiome with downstream metabolic and immune effects. California table grapes contain a complex mixture of phenolics, resveratrol, flavans, flavonols, and anthocyanins, making them ideal candidates for investigating gastrointestinal and immune health. However, previous grape-microbiome studies have been limited by small sample sizes (n=21-29), short durations (2 weeks), low-resolution microbiome technologies (16S profiling), and failure to measure corresponding inflammatory or immune biomarkers.
This project will first conduct a microbiome screening phase in up to 300 healthy adults to identify individuals who meet pre-specified microbiome and other study eligibility criteria. Eligible individuals may then be invited to participate in a rigorous, multi-omic pilot study using standardized freeze-dried grape powder to determine how daily grape consumption modulates the gut microbiome-immune axis in up to 40 healthy adults. The study team will employ state-of-the-art metagenomic sequencing to achieve high-resolution microbiome profiling; metabolomic analysis; and immune biomarker profiling to assess gastrointestinal inflammation.
Specific Aims
Overarching Goal: To build on our unique expertise in high-resolution microbiome analyses to conduct a rigorous, multi-omic pilot study determining how daily consumption of California table grape powder modulates the human gut microbiome-immune axis in healthy adults.
Hypothesis: Compared to a placebo, daily consumption of California table grape powder will beneficially modulate the gut microbiome by: (1) altering microbial composition; (2) shifting the fecal metabolome to increase grape-derived and microbial-derived anti-inflammatory compounds; and (3) reducing baseline biomarkers of gastrointestinal inflammation.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Gang Fang, PhD
- Número de teléfono: 212-659-1570
- Correo electrónico: gang.fang@mssm.edu
Copia de seguridad de contactos de estudio
- Nombre: Edward A Mead, PhD
- Número de teléfono: 212-659-6844
- Correo electrónico: edward.mead@mssm.edu
Ubicaciones de estudio
-
-
New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
-
Contacto:
- Gang Fang, PhD
- Número de teléfono: 212-659-1570
- Correo electrónico: gang.fang@mssm.edu
-
Contacto:
- Edward A Mead, PhD
- Número de teléfono: 212-659-6844
- Correo electrónico: edward.mead@mssm.edu
-
Investigador principal:
- Gang Fang, PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria
- Healthy adults between the ages of 45 and 65 years old
- Body Mass Index (BMI) within the range of 18.5 to 25.9 kg/m²
- Willing and able to provide informed consent
- Agreement to maintain usual dietary patterns throughout the study, except for the provided study powder
- Agreement to avoid exclusion criteria (below) during the study period
- Able and willing to collect and mail a stool sample during the microbiome screening phase and, if enrolled in the intervention phase, and at the three defined study timepoints
- For enrollment into the intervention phase, meeting pre-specified microbiome eligibility criteria based on the screening stool sample, as defined in the study protocol.
Exclusion Criteria
- Antibiotic use within 6 months prior to enrollment, or any planned antibiotic use during the study
- Recent initiation of or dose change in any medication or supplement within 3 months prior to enrollment, or planned initiation or dose change during the study
- Initiation or change of probiotic, prebiotic, or synbiotic supplements during the study. Existing long-term stable probiotic use is permitted
- Current or recent (within 3 months) systemic corticosteroid, biologic, DMARD, chemotherapy, or other immunosuppressive therapy; regular NSAID use (more than 2 doses per week); or planned initiation of any of the above during the study
- Active inflammatory bowel disease, irritable bowel syndrome with current symptoms, celiac disease, microscopic colitis, active diverticulitis, or acute gastrointestinal infection within 3 months; any history of C. difficile infection; or prior bariatric surgery or bowel resection
- Uncontrolled or unstable chronic disease, including but not limited to uncontrolled diabetes (HbA1c >8%), chronic hepatitis B or C, cirrhosis, moderate-to-severe chronic kidney disease (eGFR <60), active or recent (within 5 years) malignancy, solid organ or bone marrow transplant, or uncontrolled cardiovascular or psychiatric illness
- Planned major change in diet, physical activity, or lifestyle during the study period; recent significant weight change (>5% in 3 months); or current adherence to an extreme dietary pattern (strict vegan, ketogenic, carnivore, or very-low-carb) maintained for more than 3 months
- Habitual high polyphenol intake, including daily consumption of more than 2 servings of berries, more than 500 mL of red wine, more than 4 cups of tea, or regular consumption of pomegranate, grape juice, or dark chocolate more than 3 times per week, as assessed by screening food-frequency questionnaire
- Heavy alcohol use (more than 14 drinks per week), current tobacco use, or daily cannabis use
- Known grape allergy or sensitivity; pregnancy, planned pregnancy, or breastfeeding during the study; current participation in other interventional clinical trials; or any condition that, in the investigator's judgment, would compromise study participation, compliance, or data interpretation
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Grape Powder
Receive grape powder for consumption during intervention stage.
|
72 g of grape powder for daily consumption for 28 days.
|
|
Comparador de placebos: Control
Receive placebo control powder for consumption during intervention stage.
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72 g of matching placebo for daily consumption for 28 days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Long read sequencing
Periodo de tiempo: 3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Sequencing DNA from fecal samples to identify bacteria.
This will assess whether the grape powder induces a change in the abundance of beneficial species/decrease in harmful species, following treatment, compared to control.
This will be quantitatively assessed via sequencing.
|
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fecal metabolites profile from LC-MS/MS
Periodo de tiempo: 3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Fecal metabolites as measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
|
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
|
Fecal calprotectin level measured by ELISA
Periodo de tiempo: 3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Fecal calprotectin as measured by ELISA.
Elevated levels of calprotectin are a sensitive indicator of mucosal irritation.
|
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
|
Fecal albumin level measured by ELISA
Periodo de tiempo: 3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Fecal albumin as measured by ELISA.
Fecal albumin serves as a proxy for intestinal permeability, as its presence in the gut lumen suggests a leak across the epithelial barrier.
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3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
|
Fecal Lipocalin-2 measured by ELISA
Periodo de tiempo: 3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Fecal Lipocalin-2 as measured by ELISA.
Fecal Lipocalin-2 is produced by both epithelial and immune cells in response to bacterial stressors.
|
3 collections at T0 (after 3 weeks of dietary control), at week 4 (after grape or placebo powder daily), and at week 8 (after 4 weeks of returning back to normal diet)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Gang Fang, PhD, Icahn School of Medicine at Mount Sinai
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2026
Publicado por primera vez (Actual)
1 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY-26-00544
- IN300001209 (Otro número de subvención/financiamiento: California Table Grape Commission)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All of the individual participant data collected during the trial, after deidentification.
Marco de tiempo para compartir IPD
Beginning 3 months and ending 5 years following article publication.
Criterios de acceso compartido de IPD
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
To achieve aims in the approved proposal.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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