Crohn DiseaseNCT05972694
Effect of Grapes in Inflammatory Bowel Disease
A study testing Freeze dried grape powder in people with Crohn Disease, run by Case Western Reserve University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Freeze dried grape powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: 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).
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.
- Conditions
- Crohn Disease
- Being tested
- Freeze dried grape powder
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze dried grape powderDietary supplement
46g/d freeze-dried grape powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Freeze dried grape powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal microbiota composition
16S microbiome
Measured: baseline (pre-intervention), immediately after the intervention
Secondary outcomes (3)
fecal myleoperoxidase (MPO)
fecal marker of inflammation
Measured: baseline (pre-intervention), immediately after the intervention
fecal calprotectin
fecal marker of inflammation
Measured: baseline (pre-intervention), immediately after the intervention
C-reactive protein (CRP)
blood marker of inflammation
Measured: baseline (pre-intervention), immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start16 Sep 2024
- Primary completion1 Aug 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- California Table Grape Commission
- Responsible party
- Sponsor
- Investigators
- Abigail Basson, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972694
- Sponsor's protocol ID
- STUDY20230070
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Grapes in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05972694
- Acronym / sponsor ID
- STUDY20230070
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- California Table Grape Commission
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried Grape powder intervention | Experimental | Dietary Supplement: Freeze dried grape powderparticipants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freeze dried grape powder46g/d freeze-dried grape powder | Dietary supplement | Freeze-dried Grape powder intervention |
Primary outcome
fecal microbiota composition
Time frame: baseline (pre-intervention), immediately after the intervention
16S microbiome
3 secondary outcomes
fecal myleoperoxidase (MPO)
Time frame: baseline (pre-intervention), immediately after the intervention
fecal calprotectin
Time frame: baseline (pre-intervention), immediately after the intervention
C-reactive protein (CRP)
Time frame: baseline (pre-intervention), immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 42356234Eftekhar 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.
- California Table Grape CommissionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Basson, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze dried grape powder in people with Crohn Disease, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal microbiota composition (time frame: baseline (pre-intervention), immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.