Grapes for Crohn's Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Case Western Reserve University
Must not be taking: Probiotics, Antibiotics
Disqualifiers: Short bowel syndrome, Pregnancy, others
No Placebo Group
Trial Summary
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).
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.
12345Is 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.
14678How 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.
4791011Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
Case Western Reserve UniversityLead Sponsor
California Table Grape CommissionCollaborator
References
Reproduction study of grape colour extract in rats. [2019]The effect of Welch's Special Grape Color Powder Type BW-AT on reproductive performance was studied through two generations of Sprague-Dawley rats and a subchronic study was carried out on the F1 animals. The grape colour powder at dietary levels of 7.5 and 15.0% (w/w) had no adverse effects on reproductive performance. Body weights for F0 and F1 generation pups at both dose levels were significantly lower (P less than 0.05) than those of control pups at 21 days after birth. During the 13-wk subchronic feeding study of F1 rats, the body-weight gain of female rats in the high-dose group was reduced compared with the controls (P less than 0.05). Food conversion data was comparable among groups, thus the decrease in body-weight gain during this phase was most likely the result of the lower calorific value (w/w) of the feed supplemented with the grape colour powder compared with the control feed. No toxic effects or pathological changes were noted in rats fed grape colour powder.
Nutritional Regimes Enriched with Antioxidants as an Efficient Adjuvant for IBD Patients under Infliximab Administration, a Pilot Study. [2022]Antioxidants are privileged candidates for the development of adjuvants able to improve the efficiency of pharmacological therapies, particularly for chronic inflammatory syndromes. During the last 20 years, anti-TNFα (tumor necrosis factor alpha) monoclonal antibodies infusion has been the biological therapy most frequently administered but there is still large space for improvement in disease remission rates and maintenance. In this context, nutritional bioactive compounds contained in dietary patterns or included as supplements, may act as adjuvants for the induction and maintenance of IBD (inflammatory bowel diseases) remission. To verify this possibility, a single-center preliminary study (SI-CURA, Soluzioni Innovative per la gestione del paziente e il follow up terapeutico della Colite UlceRosA) was designed and carried out to evaluate whether a daily administration of purple corn supplement could improve the response to Infliximab (IFX) infusion of IBD patients with both Crohn's disease (CD) and ulcerative colitis (UC). A cohort of 47 patients was enrolled in the study. Biological samples were collected before the first and the third IFX infusion. All patients received nutritional guidelines, 27 of them received commercial red fruit tea with low anthocyanins content, while 20 received a purple corn supplement with a high anthocyanin content. Results show that the administration of an antioxidant-enriched purple corn supplement could improve IFX-mediated disease remission in terms of circulating inflammatory markers. Comparison between CD and UC patients revealed that, at this anthocyanin dosage, the purple corn extract administration improved the IFX response in CD but not in UC patients. Our results may pave the way for a new metacentric study of CD patients, recruiting a wider cohort and followed-up over a longer observational time.
The anti-inflammatory potential of phenolic compounds in grape juice concentrate (G8000™) on 2,4,6-trinitrobenzene sulphonic acid-induced colitis. [2013]Chronic inflammatory bowel disease is characterised by an up-regulation of the synthesis and release of a variety of pro-inflammatory mediators leading to excessive tissue injury. Flavonoids are able to inhibit enzymes and/or due to their antioxidant properties regulate the immune response. The goal of the present study was to evaluate the mechanisms of action of phenolic compounds present in grape juice on 2,4,6-trinitrobenzene sulphonic acid (TNBS)-induced colitis. A total of forty-one male Wistar rats were randomised into seven groups: negative control group; TNBS non-treated induced colitis; 2% grape juice control group; 1% grape juice 24 h after TNBS colitis induction; 1% grape juice on day 7 after colitis induction; 2% grape juice 24 h after colitis induction; 2% grape juice on day 7 after colitis induction. The 1% grape juice-treated induced colitis group showed marked clinical improvement when compared with the TNBS-induced colitis group. Rats that received 1% grape juice, on day 7 after colitis induction, presented reduced intensity of macroscopic and histological scores. Statistically significant differences (P,0·05) of TNF-a and inducible NO synthase mRNA expression were detected in the groups treated with grape juice at the 1% dose after inducing experimental colitis when compared with the TNBS group. Grape juice reduced the noxious effects induced by colitis caused by TNBS, especially at the 1% dose.
Characterization of critical physical and mechanical properties of freeze-dried grape powder for development of a clinical patient delivery system. [2018]Grapes are hypothesized to be a "food medicine." Freeze-dried grape powder (FDGP) is being used to test clinical activity for a variety of applications and a reproducible and reliable delivery system was required. The FDGP was characterized using traditional physico-chemical methods to generate the data needed to identify its primary liability, i.e. moisture sorption. Above a threshold level of moisture content (~25% w/w, at RT), the material becomes both difficult to handle and exhibits significant degradation of several potentially clinically important chemical components (catechin, epicatechin, resveratrol). A moisture sorption isotherm was then used to tie the threshold to the exposure relative humidity above which this occurs. Kinetic uptake studies were used to estimate the maximum safe exposure time at a given humidity (a square root time dependence of moisture uptake was observed). Armed with this knowledge, a FDGP compact coated with a compression coat [100% bees wax or combinations of carnauba wax (70%) with HPC (30%) or Avicel(®) PH 102 (30%) or lactose monohydrate (30%)] was developed that will insure the shelf life of the material without the need for special handling for approximately more than 3 months.
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]Inflammatory bowel disease (IBD) is a common chronic gastrointestinal disorder characterized by alternating periods of remission and active intestinal inflammation. Flavonoids exert several biological activities, which are mainly related to their ability to inhibit inflammatory process and/or to their antioxidant properties, and are able to regulate the immune response. The aim of this study was to evaluate whether phenolic compounds present in grape juice could reduce the inflammatory effects induced by experimental colitis. A total of 41 male Wistar rats were randomized into seven groups, as follows: G1--Sham group: sham induced-colitis rats; G2--(2,4,6-rinitrobenzenesulfonic acid) TNBS group: nontreated induced-colitis; G3--2% grape juice control group; G4--1% grape juice 24h after TNBS colitis induction; G5--1% grape juice on day 7 after colitis induction; G6--2% grape juice 24h after colitis induction; G7--2% grape juice on day 7 after colitis induction. Genotoxicity was evaluated by comet assay. Immunohistochemistry was determined using the streptavidin-biotin-peroxidase method being analyzed in control (normal tissue) and "hot spot" areas i.e., presenting inflammatory process being graded as 1 (weak), 2 (moderate), or 3 (strong). Both parameters were evaluated in the cytoplasm of epithelial or inflammatory cells. TNF-immunoexpression and iNOS were reduced after drinking grape juice 24 h or after 7 days for all doses tested. COX-2 was reduced in the groups exposed to 1% grape juice 24 h or 7 days of exposure. The grape juice at 1% dose in the last 7 days of treatment as well as grape juice at 2% dose decreased the peripheral blood genotoxicity. Taken together, the grape juice mainly at 1% dose exerts anti-inflammatory effects in chronic colitis caused by TNBS as a result of down regulation in the expression of pro-inflammatory cytokines and reduction of genotoxicity in peripheral blood cells.
[Research of grape seed powder on serum lipids and hepatic protection effects in high-fat diet rats]. [2014]To research of grape seed powder on serum lipids and hepatic protection effects in high-fat diet rats.
Safety and efficacy of 'dry grape extract 60-20' when used as feed flavouring for dogs. [2023]The feed additive 'dry grape extract 60-20' is a mixture of two extracts, one from the seed and the other from the skin of Vitis vinifera subsp. vinifera. It is intended to be used as a sensory additive (functional group: flavouring compound) in dogs. The additive 'dry grape extract 60-20' is specified to contain ■■■■■ The applicant proposes a maximum use level of 100 mg 'dry grape extract 60-20'/kg of complete feedingstuffs for dogs without a withdrawal period. The FEEDAP Panel was aware of case reports indicating acute toxicity for some dogs consuming grapes or raisins at exposure levels relevant to the use of 'dry grape extract 60-20'. The FEEDAP Panel considered that rare idiosyncratic effects could be possibly responsible for the reported cases of fatality in dogs due to acute renal failure following exposure to different types of grapes. The FEEDAP Panel considered that the additive is poorly characterised. Based on the data available, the FEEDAP Panel was not able to conclude on the safety of 'dry grape extract 60-20' when used as a feed additive for dogs. In the absence of studies to assess the safety for the user, the FEEDAP Panel could not conclude on the safety for the user when handling the additives. Since grape seed extract is used in food as flavouring, and its function in feed is essentially the same as that in food no further demonstration of efficacy was necessary.
Grape Seed Polyphenols Ameliorated Dextran Sulfate Sodium-Induced Colitis via Suppression of Inflammation and Apoptosis. [2020]Ulcerative colitis (UC) is an inflammatory bowel disease. Its onset is typically gradual, usually followed by periods of spontaneous remission and subsequent relapses. Grape seed polyphenols (GSP), a natural product extracted from grape seeds, have strong anti-inflammatory functions.
Effect of commercial grape extracts on the cheese-making properties of milk. [2018]Grape extracts can be added to milk to produce cheese with a high concentration of polyphenols. Four commercial extracts from whole grape, grape seed, and grape skin (2 extracts) were characterized and added to milk at concentrations of 0, 0.1, 0.2, and 0.3% (wt/vol). The effect of grape extracts on the kinetics of milk clotting, milk gel texture, and syneresis were determined, and model cheeses were produced. Whole grape and grape seed extracts contained a similar concentration of polyphenolic compounds and about twice the amount found in grape skin extracts. Radical scavenging activity was directly proportional to the phenolic compounds content. When added to milk, grape extracts increased rennet-induced clotting time and decreased the clotting rate. Although differences were observed between the extracts, the concentration added to milk was the main factor influencing clotting properties. With increasing concentrations of grape extracts, milk gels showed increased brittleness and reduced firmness. In addition, syneresis of milk gels decreased with increasing concentrations of grape extracts, which resulted in cheeses with a higher moisture content. The presence of grape extracts in milk slightly increased protein recovery in cheese but had no effect on fat recovery. With whole grape or grape seed extracts added to milk at 0.1% (wt/vol), the recovery coefficient for polyphenols was about 0.63, and decreased with increasing extract concentration in milk. Better polyphenol recovery was observed for grape seed extracts (0.87), with no concentration effect. Commercial extracts from whole grape, grape seed, or grape skin can be added to milk in the 0.1 to 0.3% (wt/vol) concentration range to produce cheese with potential health benefits, without a negative effect on cheese yield.
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]The stability of microparticles of Bordo grape skin aqueous extract, produced by spray-drying and freeze-drying using polydextrose (5%) and partially hydrolyzed guar gum (5%), was evaluated under accelerated conditions (75 and 90% relative humidity, at 35, 45, and 55°C for 35days) and simulated gastrointestinal digestion. The temperature had a significant effect on the reduction of phenolics content, with retentions varying from 82.5 to 93.5%. The retention of total monomer anthocyanins were in the range of 3.9-42.3%. The antioxidant activity had a final retention of 38.5-59.5%. In the simulated gastrointestinal digestion, a maximum release was observed for the phenolic compounds in the intestinal phase (90.6% for the spray-dried powder and 94.9% for the freeze-dried powder), as well as the antioxidant activity (69.4% for the spray-dried powder and 67.8% for the freeze-dried powder). However, a reduction of monomeric anthocyanins was observed in the intestinal phase.
Grape seed extract for foodborne virus reduction on produce. [2023]Grape seed extract (GSE) is reported to have antibacterial properties with few current studies on antiviral activity. Recently, we reported the effects of GSE against foodborne viral surrogates in vitro. This study evaluated the application of GSE (commercial Gravinol-S) against hepatitis A virus (HAV) and human norovirus surrogates, feline calicivirus (FCV-F9) and murine norovirus (MNV-1), on model produce. Washed and air-dried lettuce (3 × 3 cm(2)) and jalapeno peppers (25-30 g) were inoculated with FCV-F9, MNV-1, or HAV at high (∼7 log10 PFU/ml) or low (∼5 log10 PFU/ml) titers, and treated with 0.25, 0.5, 1 mg/ml GSE or water for 30 s to 5 min. Treatments were stopped/diluted with cell-culture media containing 10% heat-inactivated fetal bovine serum and evaluated using plaque assays. At high titers, FCV-F9 was reduced by 2.33, 2.58, and 2.71 log10 PFU on lettuce; and 2.20, 2.74, and 3.05 log10 PFU on peppers after 1 min using 0.25, 0.50, and 1 mg/ml GSE, respectively. Low FCV-F9 titers could not be detected after 1 min at all three GSE concentrations. Low titer MNV-1 was reduced by 0.2-0.3 log10 PFU on lettuce and 0.8 log10 PFU on peppers, without reduction of high titer. GSE at 0.25-1 mg/ml after 1 min caused 0.7-1.1 and 1-1.3 log10 PFU reduction for high and low HAV titers, respectively on both commodities. Instrumental color analysis showed no significant differences between treated and untreated produce. GSE shows potential for foodborne viral reduction on produce as part of hurdle technologies.