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CompletedNCT05972694Updated Mar 5, 2026

Effect of Grapes in Inflammatory Bowel Disease

An interventional study of Freeze dried grape powder in Crohn Disease, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Case Western Reserve University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Crohn Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 21 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Case Western Reserve University is the lead sponsor of 158 studies on the registry; 29 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementFreeze dried grape powder

    46g/d freeze-dried grape powder

06

What researchers measure

Primary outcomes

  1. fecal microbiota composition

    16S microbiome

    Time frame: baseline (pre-intervention), immediately after the intervention

Secondary outcomes

  1. fecal myleoperoxidase (MPO)

    fecal marker of inflammation

    Time frame: baseline (pre-intervention), immediately after the intervention

  2. fecal calprotectin

    fecal marker of inflammation

    Time frame: baseline (pre-intervention), immediately after the intervention

  3. C-reactive protein (CRP)

    blood marker of inflammation

    Time frame: baseline (pre-intervention), immediately after the intervention

07

Study locations

1 site
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
08

References and documents

Publications

  • Eftekhar MS, Singh D, Katz J, Nguyen V, Menghini P, Rodriguez-Palacios A, Cominelli F, Raffner Basson A. Effect of Short-Term Grape Powder Supplementation in Patients with Crohn's Disease: A Pilot Study. Nutrients. 2026 Jun 8;18(12):1844. doi: 10.3390/nu18121844. PubMed 42356234 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05972694
Lead sponsor
Case Western Reserve University
Collaborators
California Table Grape Commission
Responsible party
Sponsor
First posted
Aug 2, 2023
Start date
Sep 16, 2024
Primary completion
Aug 1, 2025
Completion
Feb 15, 2026
Last update
Mar 5, 2026

Study contacts

Abigail Basson, PhD
principal investigator · Case Western Reserve University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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