Effect of Grapes in Inflammatory Bowel Disease

NCT05972694 | Completed DMC

• 1 other identifier: STUDY20230070
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• fecal microbiota composition

  16S microbiome

  baseline (pre-intervention), immediately after the intervention

Secondary Outcomes (3)

• fecal myleoperoxidase (MPO)

  baseline (pre-intervention), immediately after the intervention

• fecal calprotectin

  baseline (pre-intervention), immediately after the intervention

• C-reactive protein (CRP)

  baseline (pre-intervention), immediately after the intervention

Study Arms (1)

Freeze-dried Grape powder intervention

EXPERIMENTAL

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

Freeze dried grape powder DIETARY_SUPPLEMENT

46g/d freeze-dried grape powder

Freeze-dried Grape powder intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead
• California Table Grape Commission: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Links

• California Table Grape Commission

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Abigail Basson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: September 16, 2024
• Primary Completion: August 1, 2025
• Study Completion: February 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)