Plant-Derived Phenolics for Leaky Gut Syndrome

Overseen By Chad Cook

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brightseed

Must not be taking: Antibiotics, Anti-inflammatories, Probiotics

Disqualifiers: GI conditions, Diabetes, Hypertension, Cancer, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a dietary supplement made from plant-derived phenolics to determine its effect on gut health in individuals with leaky gut syndrome. Researchers compare two different doses of the supplement against a placebo to identify the most effective option. The trial targets generally healthy adults at higher risk of gut issues due to a large waistline and high body weight. Participants should not use tobacco or marijuana and must maintain a consistent lifestyle and diet during the study. As an unphased trial, this study allows participants to contribute to groundbreaking research that could provide new insights into gut health.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial requires participants to refrain from using medications and supplements that influence GI function, such as anti-inflammatory drugs, pre- and probiotics, fiber supplements, laxatives, and others, starting 2 weeks before the trial and throughout the study period. However, stable use of hypertension medication is allowed if there has been no change in the regimen for 3 months prior to the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that plant-derived phenolics, natural substances found in plants, are generally safe for humans. These compounds are common in many foods and often used for their health benefits. Research indicates that the body does not easily absorb them, which usually prevents harmful effects.

Some studies suggest these compounds can improve gut health by strengthening the gut's natural barrier. This barrier helps prevent harmful substances from entering the bloodstream, which is important for overall health. No major reports of serious side effects linked to plant-derived phenolics have emerged in the studies reviewed, suggesting they are well-tolerated by most people.

For those considering joining a trial involving plant-derived phenolics, it is reassuring to know they have a history of safety in other settings. Always discuss any new treatment or supplement with a healthcare professional to ensure it fits personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for leaky gut syndrome, which typically involve dietary changes, probiotics, or supplements like L-glutamine, plant-derived phenolics offer a novel approach by harnessing the natural compounds found in plants. Researchers are excited about these treatments because they target gut health through a unique mechanism, potentially acting as antioxidants and anti-inflammatory agents. This provides a fresh avenue for addressing the condition, possibly improving gut barrier function more effectively. Additionally, the treatment is convenient, administered in capsule form once a day, making it easy for patients to incorporate into their daily routines.

What evidence suggests that this trial's treatments could be effective for leaky gut syndrome?

Research has shown that natural compounds from plants, called phenolics, benefit gut health. These compounds boost the production of proteins that strengthen the gut lining, which is crucial for preventing harmful substances from entering the bloodstream. Additionally, a specific type of phenolic, known as polyphenols, can reduce stress in the body and support a healthy balance of gut bacteria. One study found that a diet high in phenolics reduced gut leakage in older adults, suggesting potential benefits for those with leaky gut syndrome. This trial will compare the effects of different doses of plant-derived phenolics with a placebo to evaluate their potential in improving gut health. Overall, early evidence is promising for using plant-based phenolics to enhance gut health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 30-69 with a high BMI (29.0 to <40.0) and large waist circumference (>102 cm for men, >88 cm for women), who don't use tobacco or marijuana products, can join this trial. They must be willing to keep their diet, exercise, and weight stable throughout the study.

Inclusion Criteria

Non-user of marijuana or hemp products within 6 months of Visit 1, with no plans to begin use during the study period. A washout of 7 days is required for topical products and willing to refrain from use during the study

Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial

Willing to refrain from exclusionary medications, supplements, and products throughout the study

Exclusion Criteria

I have had cancer or been cancer-free for less than 2 years.

Known sensitivity, intolerance, or allergy to any of the study products or their excipients

Abnormal chemistry or hematology laboratory test result(s) of clinical significance at Visit 1 (Day -7), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal laboratory test results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or a dietary supplement containing plant-derived phenolics at two different dose levels for 42 days

6 weeks

1 visit (in-person) at the start, 1 visit (in-person) at the end

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Microcrystalline cellulose
• Plant derived phenolics

Trial Overview The trial is testing if taking dietary supplements with plant derived phenolics improves gut health in adults at risk of leaky gut syndrome due to obesity. Participants will receive either the supplement at two dose levels or a placebo.

How Is the Trial Designed?

Group I: Active low dose of plant derived phenolics Active Control 1 Intervention

Active low dose of plant derived phenolics via 1 capsule/d

Group II: Active high dose of plant derived phenolics Active Control 1 Intervention

Active high dose of plant derived phenolics via 1 capsule/d

Group III: Placebo treatment Placebo Group 1 Intervention

Placebo treatment (Microcrystaline cellulose): 1 capsule/d

Who Is Running the Clinical Trial?

Brightseed

Lead Sponsor

Trials

6

Recruited

560+

Published Research Related to This Trial

Current research indicates that there is limited evidence of overt toxicity from consuming high doses of (poly)phenol-rich sources like green tea extracts and grape-derived phenolics, suggesting they may be safe for regular consumption.

However, more studies are needed to determine what constitutes a 'high' dose of (poly)phenols and to better understand their safety, especially as consumer interest in these supplements grows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(Poly)phenol toxicity in vivo following oral administration: A targeted narrative review of (poly)phenols from green tea, grape, and anthocyanin-rich extracts. Cladis, DP., Weaver, CM., Ferruzzi, MG.[2022]

Chlorogenic acid (CGA), a natural phenolic compound, has demonstrated significant anti-inflammatory and pain-relieving effects in animal models, suggesting its potential as a therapeutic agent.

CGA may help manage pain by enhancing the body's antioxidant defenses against inflammation, highlighting its role in both preventing and treating conditions related to oxidative stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic Overview of Chlorogenic Acid and its Metabolites in Chronic Pain and Inflammation. Bagdas, D., Gul, Z., Meade, JA., et al.[2020]

Plant-derived polyphenols can enhance the function of the intestinal epithelial barrier, which is crucial for preventing various gastrointestinal diseases and systemic conditions.

These compounds exert their beneficial effects through specific regulatory pathways that improve tight junction integrity, suggesting their potential as nutraceuticals for managing intestinal inflammatory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of the intestinal tight junction by natural polyphenols: A mechanistic perspective. Yang, G., Bibi, S., Du, M., et al.[2020]

Phenolic compounds, which are important plant metabolites, may help prevent degenerative diseases like cancer and cardiovascular diseases due to their antioxidant properties.

There is still limited data on how well phenolic compounds are absorbed and metabolized in humans, indicating a need for more research to understand their effectiveness and bioavailability in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of phenolic compounds. Karakaya, S.[2022]

Natural phenolic compounds found in plants and food by-products show promising benefits for intestinal health and may serve as alternative therapies for inflammatory bowel diseases (IBD), which include Crohn's disease and ulcerative colitis.

These compounds are abundant, low-cost, and safe, making them an attractive option for developing new treatments that could help manage IBD without the side effects associated with conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyphenols from food by-products: An alternative or complementary therapy to IBD conventional treatments. Machado, APDF., Geraldi, MV., do Nascimento, RP., et al.[2021]

Phenolic compounds are divided into two main groups: flavonoids and non-flavonoids, each with various subclasses, highlighting their diverse properties and potential applications.

Polyphenols have significant health benefits, particularly in relation to cardiovascular diseases, diabetes, and cancer, making them valuable for both food preservation and therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyphenols: A concise overview on the chemistry, occurrence, and human health. Durazzo, A., Lucarini, M., Souto, EB., et al.[2020]

Polyphenols can improve cardiovascular health, as indicated by their ability to enhance flow-mediated dilation (FMD), a key biomarker for cardiovascular risk, with acute effects peaking around 2 hours after consumption.

The effectiveness of polyphenols is linked to their metabolites acting on specific enzymes like NADPH oxidases, rather than just their antioxidant properties, highlighting the need for more precise research methods over general antioxidant capacity assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyphenols and health: update and perspectives. Sies, H.[2014]

Regular consumption of fresh fruits and vegetables, which are rich in plant phenolics, is linked to a lower risk of cancer, supported by both human studies and experimental research.

Plant phenolics may inhibit cancer development not only through antioxidant properties but also by modulating important metabolic pathways, suggesting their potential as effective agents in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant phenolics as potential cancer prevention agents. Newmark, HL.[2019]

Natural phenolic compounds from medicinal herbs and dietary plants have significant roles in cancer prevention and treatment due to their various bioactivities, including antioxidant and anti-inflammatory effects.

These compounds can induce apoptosis and inhibit cancer cell growth by affecting cell cycle regulation, DNA binding, and signaling pathways, highlighting their potential as effective chemopreventive agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural phenolic compounds from medicinal herbs and dietary plants: potential use for cancer prevention. Huang, WY., Cai, YZ., Zhang, Y.[2022]

Polyphenols can positively influence energy metabolism by selectively promoting beneficial gut bacteria and inhibiting harmful ones, which helps maintain a healthy balance in the intestinal microbiota.

The interaction between polyphenols and intestinal microecology affects not only the growth of microorganisms but also the function of intestinal cells and the immune system, highlighting the importance of gut health in energy regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of intestinal microecology in the regulation of energy metabolism by dietary polyphenols and their metabolites. Lin, S., Wang, Z., Lam, KL., et al.[2022]

Phenolic compounds, although not essential for human growth, can significantly influence health by affecting gut microbiota and promoting colonic health, as highlighted in this review of their mechanisms of action.

A diet rich in phenolic compounds can lead to beneficial changes in gut microbiota, resulting in anti-inflammatory, antioxidant, and antiproliferative effects in the colon, which may enhance overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phenolic Compounds Promote Diversity of Gut Microbiota and Maintain Colonic Health. Domínguez-Avila, JA., Villa-Rodriguez, JA., Montiel-Herrera, M., et al.[2021]

Citations

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Leaky Gut and the Ingredients That Help Treat It: A Review The research on treating the intestinal permeability is mostly based on avoidance of high amounts of sugar and fat and implementation of FODMAP (fermentable ...

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Polyphenols and Intestinal Permeability: Rationale and Future ... The results from in vitro studies have shown the capacity of PPs to increase the expression and/or production of numerous TJ proteins and to ...

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A fruitful approach to gut health and functionality Polyphenols help prevent oxidative stress, chronic diseases, and gut dysbiosis, while prebiotic fibers and short-chain fatty acids support microbial diversity ...

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Food, gut barrier dysfunction, and related diseases In this comprehensive review, our aim focused on the relationship between dietary factors, intestinal permeability dysfunction, and related diseases.

7. mdpi.com mdpi.com/2223-7747/12/6/1217

Recent Developments in Polyphenol Applications on ... Inclusions of polyphenolic compounds in various foods have demonstrated their ability to extend shelf life and they positive impacts on human health ( ...

8. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-020-1472-9

Effect of a polyphenol-rich dietary pattern on intestinal ... Evidence that increasing the consumption of polyphenol-rich food products can positively affect intestinal microbial ecosystem resulting in reduced IP