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NCT Number: NCT05972694

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freeze dried grape powder

Dietary Supplement

46g/d freeze-dried grape powder

Primary outcomes

  1. fecal microbiota composition

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

    16S microbiome

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • California Table Grape Commission

Registry information

Official study title

The Effect of Grapes in Inflammatory Bowel Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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