20 Participants Needed

Grapes for Crohn's Disease

AB
ML
Overseen ByMegan Luskin
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must not have changed your IBD medication in the past 4 weeks and should not have used probiotics or antibiotics in the last 14 days.

What evidence supports the effectiveness of the treatment for Crohn's Disease?

Research suggests that grape juice, which contains similar phenolic compounds to those in freeze-dried grape powder, has anti-inflammatory effects in experimental colitis, a condition similar to Crohn's Disease. This indicates potential benefits of grape-derived treatments in reducing inflammation.12345

Is freeze-dried grape powder safe for human use?

Research on grape color powder in rats showed no toxic effects or harmful changes, but it did affect body weight due to lower calorie content. However, there is no direct safety data for freeze-dried grape powder in humans.14678

How does freeze-dried grape powder treatment for Crohn's disease differ from other treatments?

Freeze-dried grape powder is unique because it uses natural compounds found in grapes, like catechin and resveratrol, which are thought to have health benefits. Unlike traditional medications, this treatment is derived from food and focuses on leveraging the antioxidant properties of grapes to potentially help manage Crohn's disease.4791011

What is the purpose of this trial?

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).

Research Team

AB

Abigail Basson, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

This trial is for adults who can consent to participate, are able to take oral nutrition, complete daily surveys, and record their meals. They must have a confirmed diagnosis of Crohn's disease but currently be in remission as indicated by a Harvey Bradshaw index score of less than 5.

Inclusion Criteria

Your Harvey Bradshaw-index score is below 5, indicating that your Crohn's disease symptoms are in remission.
You are capable of completing surveys and providing oral nutrition on a daily basis.
I can keep a daily record of what I eat.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants remove all grapes and berries from their diet

1 week
1 visit (in-person)

Intervention

Participants are supplemented with 46g/day freeze-dried grape powder

3 weeks
1 visit (in-person)

Follow-up

Participants are monitored for changes in gut microbiota composition and inflammation markers

1 week

Treatment Details

Interventions

  • Freeze dried grape powder
Trial Overview The study tests the effects of consuming freeze-dried grape powder (46g/day) on gut bacteria composition in patients with Crohn's Disease. It aims to see if grapes can influence the condition positively.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Freeze-dried Grape powder interventionExperimental Treatment1 Intervention
participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

California Table Grape Commission

Collaborator

Trials
8
Recruited
270+

Findings from Research

Welch's Special Grape Color Powder Type BW-AT did not adversely affect reproductive performance in Sprague-Dawley rats over two generations, indicating its safety for reproductive health.
While the grape color powder led to lower body weights in both generations of pups and reduced body-weight gain in female F1 rats during a 13-week study, these effects were attributed to the lower calorific value of the supplemented feed rather than toxicity.
Reproduction study of grape colour extract in rats.Becci, PJ., Hess, FG., Babish, JG., et al.[2019]
A preliminary study involving 47 patients with inflammatory bowel diseases (IBD) suggested that a daily purple corn supplement, rich in antioxidants, may enhance the effectiveness of Infliximab (IFX) infusions, particularly in patients with Crohn's disease.
The results indicated that while the purple corn supplement improved inflammatory markers in Crohn's disease patients, it did not have the same effect in those with ulcerative colitis, highlighting the need for further research focused on Crohn's disease.
Nutritional Regimes Enriched with Antioxidants as an Efficient Adjuvant for IBD Patients under Infliximab Administration, a Pilot Study.Liso, M., Sila, A., Verna, G., et al.[2022]
In a study involving 41 male Wistar rats, treatment with 1% grape juice after TNBS-induced colitis led to significant clinical improvement and reduced tissue damage compared to untreated colitis.
The 1% grape juice treatment resulted in lower levels of pro-inflammatory markers, such as TNF-a and inducible NO synthase, indicating its potential to mitigate inflammation and tissue injury in chronic inflammatory bowel disease.
The anti-inflammatory potential of phenolic compounds in grape juice concentrate (G8000™) on 2,4,6-trinitrobenzene sulphonic acid-induced colitis.Paiotti, AP., Neto, RA., Marchi, P., et al.[2013]

References

Reproduction study of grape colour extract in rats. [2019]
Nutritional Regimes Enriched with Antioxidants as an Efficient Adjuvant for IBD Patients under Infliximab Administration, a Pilot Study. [2022]
The anti-inflammatory potential of phenolic compounds in grape juice concentrate (G8000™) on 2,4,6-trinitrobenzene sulphonic acid-induced colitis. [2013]
Characterization of critical physical and mechanical properties of freeze-dried grape powder for development of a clinical patient delivery system. [2018]
Concentrated grape juice (G8000™) reduces immunoexpression of iNOS, TNF-alpha, COX-2 and DNA damage on 2,4,6-trinitrobenzene sulfonic acid-induced-colitis. [2014]
[Research of grape seed powder on serum lipids and hepatic protection effects in high-fat diet rats]. [2014]
Safety and efficacy of 'dry grape extract 60-20' when used as feed flavouring for dogs. [2023]
Grape Seed Polyphenols Ameliorated Dextran Sulfate Sodium-Induced Colitis via Suppression of Inflammation and Apoptosis. [2020]
Effect of commercial grape extracts on the cheese-making properties of milk. [2018]
Effect of temperature and relative humidity on stability following simulated gastro-intestinal digestion of microcapsules of Bordo grape skin phenolic extract produced with different carrier agents. [2018]
Grape seed extract for foodborne virus reduction on produce. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security