Grapes for Crohn's Disease

Overseen By Megan Luskin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Short bowel syndrome, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether grape powder can positively affect gut health in people with Crohn's disease, a condition that causes inflammation in the digestive tract. Participants will consume freeze-dried grape powder daily to observe its influence on their gut microbiota, the community of microorganisms in the intestines. Individuals with Crohn's disease who are currently in remission (not showing symptoms) may qualify, particularly if they can complete daily surveys and track their meals. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on natural interventions for gut health.

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 prior data suggests that freeze dried grape powder is safe for Crohn's disease patients?

Research shows that freeze-dried grape powder is likely safe for use. Studies on rats found no toxic effects or harmful changes from grape color powder. Research with humans also found no major negative effects from consuming grape powder. Some studies even reported benefits, such as improved gut health and metabolism. Although long-term effects remain unclear, current evidence suggests it is well-tolerated for short-term use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Crohn's Disease, which often include medications like corticosteroids and immunosuppressants, this new approach uses freeze-dried grape powder. Researchers are excited about this because grapes are rich in polyphenols, which have anti-inflammatory properties that could help soothe the gut lining. This natural treatment might offer a more gentle alternative with potentially fewer side effects, making it an appealing option for those looking for a more holistic approach. Plus, the convenience of consuming it as a simple daily supplement is a bonus for people seeking easy-to-integrate treatments.

What evidence suggests that freeze dried grape powder might be an effective treatment for Crohn's disease?

Research has shown that natural compounds in grapes, called polyphenols, may support colon health and improve overall gut health. Studies have found that grapes can positively affect gut bacteria, potentially reducing harmful inflammation associated with Crohn's disease. Consuming grapes might also prevent changes in gut bacteria linked to disease, known as dysbiosis. These findings suggest that the freeze-dried grape powder provided to participants in this trial could support a healthier gut environment for people with Crohn's disease. ^{1 3 6 7 8}

Who Is on the Research Team?

Abigail Basson, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Freeze-dried Grape powder intervention Experimental Treatment 1 Intervention

participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The feed additive 'dry grape extract 60-20', derived from Vitis vinifera, is proposed for use in dog food as a flavoring agent at a maximum level of 100 mg/kg, but its safety remains uncertain due to potential toxicity concerns related to grape consumption in dogs.

The FEEDAP Panel could not confirm the safety of 'dry grape extract 60-20' for dogs or for those handling the additive, highlighting the need for further safety studies despite its use in food as a flavoring agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 'dry grape extract 60-20' when used as feed flavouring for dogs. Bampidis, V., Azimonti, G., Bastos, ML., et al.[2023]

In a study involving 41 male Wistar rats, grape juice, particularly at a 1% concentration, significantly reduced inflammation and genotoxicity in cases of experimental colitis, indicating its potential as an anti-inflammatory agent.

The grape juice treatment led to decreased levels of pro-inflammatory markers such as TNF and COX-2, suggesting that phenolic compounds in grape juice may help regulate the immune response in inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrated grape juice (G8000™) reduces immunoexpression of iNOS, TNF-alpha, COX-2 and DNA damage on 2,4,6-trinitrobenzene sulfonic acid-induced-colitis. Marchi, P., Paiotti, AP., Artigiani Neto, R., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Freeze-dried grape powder (FDGP) can degrade and become difficult to handle if it absorbs too much moisture (above ~25% w/w), which affects its important chemical components like catechin and resveratrol.

To ensure the stability and shelf life of FDGP, a new compact coating system using beeswax and other materials was developed, allowing it to remain effective for over 3 months without special handling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of critical physical and mechanical properties of freeze-dried grape powder for development of a clinical patient delivery system. Hu, D., Haware, RV., Hamad, ML., et al.[2018]

Grape seed extract (GSE) effectively reduced the levels of the feline calicivirus (FCV-F9) on lettuce and jalapeno peppers, achieving reductions of up to 3.05 log10 PFU after just 1 minute of treatment at the highest concentration (1 mg/ml).

GSE also demonstrated the ability to reduce hepatitis A virus (HAV) levels on produce, with reductions of 0.7-1.3 log10 PFU, while showing no significant impact on the color or appearance of the treated produce, indicating its potential as a safe foodborne viral reduction method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grape seed extract for foodborne virus reduction on produce. Su, X., D'Souza, DH.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproduction study of grape colour extract in rats. Becci, PJ., Hess, FG., Babish, JG., et al.[2019]

Microparticles made from Bordo grape skin extract showed good stability under high humidity and temperature conditions, retaining 82.5% to 93.5% of their phenolic content after 35 days.

During simulated gastrointestinal digestion, these microparticles released a high percentage of phenolic compounds (up to 94.9% for freeze-dried powder), indicating potential for effective antioxidant delivery in the intestines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kuck, LS., Wesolowski, JL., Noreña, CPZ.[2018]

In a study involving rats on a high-fat diet, grape seed powder significantly reduced serum levels of total cholesterol, triglycerides, and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol, indicating its potential to improve lipid profiles.

Grape seed powder also showed protective effects on the liver, as it significantly reduced fatty degeneration compared to rats that only received a high-fat diet, suggesting it may help prevent fatty liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research of grape seed powder on serum lipids and hepatic protection effects in high-fat diet rats]. Song, C., Zhong, X., Ge, H., et al.[2014]

Grape seed polyphenols (GSP) significantly alleviate symptoms of ulcerative colitis (UC) in mice, including weight loss, diarrhea, and mucosal damage, indicating its potential as a therapeutic agent.

GSP works by reducing inflammation and apoptosis in intestinal epithelial cells, as evidenced by decreased levels of inflammatory cytokines and the phosphorylation of STAT3, suggesting a protective mechanism against UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grape Seed Polyphenols Ameliorated Dextran Sulfate Sodium-Induced Colitis via Suppression of Inflammation and Apoptosis. Wang, Y., Wang, Y., Shen, W., et al.[2020]

Adding grape extracts to milk can enhance the polyphenol content in cheese, with whole grape and grape seed extracts showing similar levels of beneficial compounds, which are linked to antioxidant activity.

The concentration of grape extracts significantly affects the milk's clotting properties and the texture of the resulting cheese, allowing for the production of cheese with higher moisture content and potential health benefits without compromising cheese yield.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of commercial grape extracts on the cheese-making properties of milk. Felix da Silva, D., Matumoto-Pintro, PT., Bazinet, L., et al.[2018]

Citations

1. trialx.com trialx.com/clinical-trials/listings/305049/effect-of-grapes-in-inflammatory-bowel-disease/

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 ...

2. withpower.com withpower.com/trial/phase-crohn-disease-3-2024-491ef

Grapes for Crohn's Disease 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286322001929

Supplementation of polyphenol-rich grapes attenuates ... Our studies demonstrate that grape polyphenols alleviate colonic diseases and prevent disease-associated dysbiosis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4933298/

A Polyphenol-Rich Fraction Obtained from Table Grapes ... The objective of this study was to determine if consuming an extractable or non-extractable fraction of table grapes reduced the metabolic consequences of ...

5. nature.com nature.com/articles/s41598-023-34813-5

Influence of grape consumption on the human microbiome A substantial body of information has accumulated suggesting dietary consumption of grapes may have a positive influence on human health.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/545637

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 ...

7. grapesfromcalifornia.com grapesfromcalifornia.com/wp-content/uploads/2021/10/20211019-guidelines-for-use-of-california-table-grape-powder-in-health-research-studies-2022-23.pdf

Guidelines for Use of California Table Grape Powder in ... A 3/4 cup serving of fresh grapes (126 g) is equivalent to 23 g of the commission freeze-dried whole table grape powder. Table Grape Powder Use in Human ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8619073/

Effect of Standardized Grape Powder Consumption on the ... In conclusion, grape powder consumption significantly modified the gut microbiome and cholesterol/bile acid metabolism. Keywords: grape powder, ...