The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Grapes in Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05972694
Recruitment Status : Not yet recruiting
First Posted : August 2, 2023
Last Update Posted : May 3, 2024
Sponsor:
Collaborator:
California Table Grape Commission
Information provided by (Responsible Party):
Abigail Basson, Case Western Reserve University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Freeze dried grape powder Not Applicable

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 28 day 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 28 days and will consist of two phases. Phase I (baseline period - 7 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 21 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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 21 days. A stool and blood sample will be collected at the start and end of the intervention.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Grapes in Inflammatory Bowel Disease
Estimated Study Start Date : July 2, 2024
Estimated Primary Completion Date : September 2, 2025
Estimated Study Completion Date : November 2, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Freeze-dried Grape powder intervention
participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.
 Dietary Supplement: Freeze dried grape powder
46g/d freeze-dried grape powder


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. fecal microbiota composition [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    16S microbiome


Secondary Outcome Measures :
  1. fecal myleoperoxidase (MPO) [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    fecal marker of inflammation

  2. fecal calprotectin [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    fecal marker of inflammation

  3. C-reactive protein (CRP) [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    blood marker of inflammation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of Crohns disease. CD outpatients in remission
  • Harvey Bradshaw-index in remission (<6 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
  • No probiotic or antibiotic use for the previous 14 days
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05972694


Contacts
Layout table for location contacts
Contact: Abigail Basson, PhD 2163276003 abigail.basson@uhhospitals.org
Contact: Megan Luskin 216-368-2440 mluskin@case.edu

Sponsors and Collaborators
Case Western Reserve University
California Table Grape Commission
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Abigail Basson, Principal Investigator, study coordinator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT05972694    
Other Study ID Numbers: STUDY20230070
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases