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Grape Impact on Human Gut Microbiome

27 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • New York
      • New York, New York, Stany Zjednoczone, 10029
        • Icahn School of Medicine at Mount Sinai
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Gang Fang, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Grape Powder
Receive grape powder for consumption during intervention stage.
Suplement diety: Grape Powder
72 g of grape powder for daily consumption for 28 days.
Komparator placebo: Control
Receive placebo control powder for consumption during intervention stage.
Inny: Placebo Powder
72 g of matching placebo for daily consumption for 28 days.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Long read sequencing
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Fecal metabolites profile from LC-MS/MS
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Icahn School of Medicine at Mount Sinai

Śledczy

  • Główny śledczy: Gang Fang, PhD, Icahn School of Medicine at Mount Sinai

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2027

Ukończenie studiów (Szacowany)

1 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

27 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

1 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY-26-00544
  • IN300001209 (Inny numer grantu/finansowania: California Table Grape Commission)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All of the individual participant data collected during the trial, after deidentification.

Ramy czasowe udostępniania IPD

Beginning 3 months and ending 5 years following article publication.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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