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Effect of Grapes in Inflammatory Bowel Disease

Primary Purpose

Crohn Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Freeze dried grape powder
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Crohn Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented diagnosis of Crohns disease. CD outpatients in remission Harvey Bradshaw-index in remission (<5 score) Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition Able to record daily meal intake Exclusion Criteria: Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients. Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture. Presence of an ostomy. Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per day. Unable to access to technology that permits the daily completion of study related activities. Change in IBD medication within past 4 weeks. Body mass Index <16 kg/m or ≥35. Documented C.difficile colitis within four weeks of screening. Known berry or grape allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Freeze-dried Grape powder intervention

    Arm Description

    participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 28 days.

    Outcomes

    Primary Outcome Measures

    fecal microbiota composition
    16S microbiome

    Secondary Outcome Measures

    fecal myleoperoxidase (MPO)
    fecal calprotectin
    Crohns Disease Activity Index
    C-reactive protein (CRP)

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    August 1, 2023
    Sponsor
    Case Western Reserve University
    Collaborators
    California Table Grape Commission
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05972694
    Brief Title
    Effect of Grapes in Inflammatory Bowel Disease
    Official Title
    The Effect of Grapes in Inflammatory Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2, 2024 (Anticipated)
    Primary Completion Date
    June 2, 2025 (Anticipated)
    Study Completion Date
    October 2, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Case Western Reserve University
    Collaborators
    California Table Grape Commission

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).
    Detailed Description
    This protocol is designed to investigate the effect of grape powder consumption in Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as 46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM) composition in humans with IBD. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions). The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease (CD). An 8-week pilot study in adult CD patients at the Digestive Health Institutes (DHI) of University Hospitals Cleveland Medical Center (UHCMC). table Participation in this study will last for a maximum of 56 days and will consist of two phases. Phase I (baseline period - 21-28 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 28 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be asked to avoid consumption of all other grapes/berries during phase II. The investigators will compare the before and after changes in gut microbiota composition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    subjects will continue to consume their usual diet (excluding all grapes/berries) and consume 46g/d freeze-dried grape powder daily (consumed as 22.5g packets twice daily for 28 days. A stool, urine and blood sample will be collected at the start and end of the intervention..
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Freeze-dried Grape powder intervention
    Arm Type
    Experimental
    Arm Description
    participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 28 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Freeze dried grape powder
    Intervention Description
    46g/d freeze-dried grape powder
    Primary Outcome Measure Information:
    Title
    fecal microbiota composition
    Description
    16S microbiome
    Time Frame
    baseline (pre-intervention), immediately after the intervention
    Secondary Outcome Measure Information:
    Title
    fecal myleoperoxidase (MPO)
    Time Frame
    baseline (pre-intervention), immediately after the intervention
    Title
    fecal calprotectin
    Time Frame
    baseline (pre-intervention), immediately after the intervention
    Title
    Crohns Disease Activity Index
    Time Frame
    baseline (pre-intervention), immediately after the intervention
    Title
    C-reactive protein (CRP)
    Time Frame
    baseline (pre-intervention), immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented diagnosis of Crohns disease. CD outpatients in remission Harvey Bradshaw-index in remission (<5 score) Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition Able to record daily meal intake Exclusion Criteria: Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients. Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture. Presence of an ostomy. Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per day. Unable to access to technology that permits the daily completion of study related activities. Change in IBD medication within past 4 weeks. Body mass Index <16 kg/m or ≥35. Documented C.difficile colitis within four weeks of screening. Known berry or grape allergy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abigail Basson, PhD
    Phone
    8562203445
    Email
    abigail.basson@uhhospitals.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan Luskin
    Phone
    216-368-2440
    Email
    mluskin@case.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.grapesfromcalifornia.com/
    Description
    California Table Grape Commission

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