Effect of Grapes in Inflammatory Bowel Disease

The Effect of Grapes in Inflammatory Bowel Disease

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).

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Dietary supplement: Freeze dried grape powder

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fecal microbiota composition	16S microbiome	baseline (pre-intervention), immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fecal myleoperoxidase (MPO)	fecal marker of inflammation	baseline (pre-intervention), immediately after the intervention
fecal calprotectin	fecal marker of inflammation	baseline (pre-intervention), immediately after the intervention
C-reactive protein (CRP)	blood marker of inflammation	baseline (pre-intervention), immediately after the intervention

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: California Table Grape Commission
• Investigators: Principal Investigator: Abigail Basson, PhD, Case Western Reserve University

Publications and helpful links

Helpful Links

• California Table Grape Commission

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): February 15, 2026

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: STUDY20230070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No