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

Trial Summary

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.

What data supports the idea that Plant-Derived Phenolics for Leaky Gut Syndrome is an effective treatment?

The available research shows that plant-derived phenolics, which are natural compounds found in plants, have several health benefits that could support their use for Leaky Gut Syndrome. These compounds are known for their antioxidant and anti-inflammatory properties, which help protect the gut lining and improve gut health. One study highlights their role in regulating the intestinal barrier, which is crucial for preventing gut-related diseases. Another study suggests that phenolic compounds can promote a healthy gut microbiota, which is important for maintaining colonic health. While these studies focus on related conditions like inflammatory bowel diseases, the benefits of phenolic compounds in improving gut health suggest they could be effective for Leaky Gut Syndrome as well. ^{1 2 3 4 5}

What safety data exists for plant-derived phenolics used in treating leaky gut syndrome?

The safety data for plant-derived phenolics, including polyphenols, is still being researched. While there is limited evidence of overt toxicity from oral ingestion of polyphenol-rich sources like green tea, grapes, and anthocyanin-rich extracts, more research is needed to understand the safety of high doses. Current studies focus on their health benefits, such as cardiovascular and cancer prevention, but caution is advised due to the lack of comprehensive safety data at high doses. ^{6 7 8 9 10}

Is the treatment Plant derived phenolics a promising treatment for Leaky Gut Syndrome?

Yes, plant-derived phenolics, also known as polyphenols, are promising for treating Leaky Gut Syndrome. They help strengthen the gut barrier, reduce inflammation, and have antioxidant properties, which can improve gut health and prevent related diseases. ^{1 2 3 8 11}

What is the purpose of this trial?

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo.

Eligibility Criteria

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

I haven't used tobacco or nicotine for at least a year and don't plan to start.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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, 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]

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 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]

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]

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 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]

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]

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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Pharmacologic Overview of Chlorogenic Acid and its Metabolites in Chronic Pain and Inflammation. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

Polyphenols from food by-products: An alternative or complementary therapy to IBD conventional treatments. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Regulation of the intestinal tight junction by natural polyphenols: A mechanistic perspective. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Phenolic Compounds Promote Diversity of Gut Microbiota and Maintain Colonic Health. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Natural phenolic compounds from medicinal herbs and dietary plants: potential use for cancer prevention. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Polyphenols and health: update and perspectives. [2014]

7. England 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Polyphenols: A concise overview on the chemistry, occurrence, and human health. [2020]

9. Sweden pubmed.ncbi.nlm.nih.gov

Role of intestinal microecology in the regulation of energy metabolism by dietary polyphenols and their metabolites. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Plant phenolics as potential cancer prevention agents. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Bioavailability of phenolic compounds. [2022]