Grape Powder for Gut Microbiome

GF
EA
Overseen ByEdward A Mead, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether consuming a specific grape powder daily can alter the gut microbiome and impact immune health in healthy adults. Researchers will divide participants into two groups: one taking the grape powder and another taking a placebo (a harmless pill with no active ingredients) for comparison. The trial aims to determine if the grape powder changes gut bacteria and immune markers over time. Ideal participants are healthy individuals with a normal body mass index who can maintain their usual diet and provide stool samples for testing. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on diet and gut health.

What prior data suggests that grape powder is safe for consumption?

Research has shown that grape powder is generally safe to consume. One study found no safety issues with dry grape extract, although grape seed extract might irritate the skin. Another study found that grape seed powder can help reduce swelling and pain in the body. These findings suggest that grape-based products, like the powder under study, are usually well-tolerated.

While these studies focus on grape seed and grape extract, they provide insight into grape powder's safety. Since these studies reported no major safety problems, grape powder appears to be a safe option for those considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Unlike many current treatments for gut health that often involve probiotics or dietary supplements targeting specific bacteria, grape powder offers a novel approach by using natural compounds found in grapes. Researchers are excited about grape powder because it contains polyphenols, which are known for their antioxidant and anti-inflammatory properties. These compounds could potentially promote a more balanced gut microbiome by supporting the growth of beneficial bacteria and reducing inflammation. This natural, food-based intervention might offer a more holistic and gentle way to improve gut health compared to synthetic supplements.

What evidence suggests that grape powder could be effective for modulating the gut microbiome?

Research has shown that grape powder, which participants in this trial may receive, benefits gut health. Studies have found that natural compounds in grapes, called polyphenols, increase beneficial bacteria like Akkermansia and Flavonifractor, reducing inflammation and improving food processing. Other research indicates that grape seed powder aids in smoother food movement through the gut. Additionally, grape polyphenols may lower harmful substances in the blood, potentially enhancing overall health. These findings suggest that grape powder could effectively boost gut health and immune function.16789

Who Is on the Research Team?

GF

Gang Fang, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for healthy adults who meet specific gut microbiome criteria based on initial screening. Participants must not have health conditions or factors that could affect the study results, as determined by the researchers.

Inclusion Criteria

Body Mass Index (BMI) within the range of 18.5 to 25.9 kg/m²
Willing and able to provide informed consent
Agreement to avoid exclusion criteria during the study period
See 4 more

Exclusion Criteria

Habitual high polyphenol intake defined as daily consumption of more than 2 servings of berries, more than 500 mL of red wine, more than 4 cups of tea, or regular consumption of pomegranate, grape juice, or dark chocolate more than 3 times per week as assessed by screening food-frequency questionnaire
I have used antibiotics in the past 6 months or plan to use them during the study.
Heavy alcohol use (more than 14 drinks per week), current tobacco use, or daily cannabis use
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Dietary Control

Participants follow a controlled diet for baseline measurements

3 weeks
1 visit (in-person)

Treatment

Participants consume either grape powder or placebo daily

4 weeks
2 visits (in-person)

Washout

Participants return to their normal diet to assess post-intervention effects

4 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Grape Powder

Trial Overview

The study tests whether taking grape powder daily for 4 weeks changes gut bacteria and immune markers compared to a placebo. It uses a randomized, double-blind design where neither participants nor researchers know who gets which powder.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Grape PowderExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

THE ROLE OF GUT MICROBES IN THE PROTECTIVE ...

In the study of grape polyphenols, we proved the causal role of gut microbes in polyphenol-mediated alleviation of colitis. In the subsequent ...

Effects of Grape Pomace Polyphenolic Extract (Taurisolo®) in ...

Among the polyphenols contained in grape pomace, RSV has been recently demonstrated to be effective in decreasing TMAO serum levels.

(PDF) Grape seed powder increases gastrointestinal motility

These results demonstrate that GSP can regulate GI motility, and therefore, it is a potential therapeutic agent for treating GI motility ...

Dietary Polyphenols Promote Growth of the Gut Bacterium ...

One possibility is that grape polyphenols (GP) act by remodeling the gut microbiota, leading to reduced inflammation and improved metabolic ...

The Effects of a Prebiotic Formula Promoting Akkermansia ...

Results: The results revealed no significant markers of liver or kidney dysfunction in either group. The AKK formula group showed an increased ...

Safety and efficacy of dry grape extract when used as a feed ...

No safety concern would arise for the consumer from the use of the dry grape extract. The grape seed extract tested are irritating to skin and ...

Grape-Seed Proanthocyanidins are Able to Reverse Intestinal ...

Grape-Seed Proanthocyanidins are Able to Reverse Intestinal Dysfunction and Metabolic Endotoxemia Induced by a Cafeteria Diet in Wistar Rats · 5. Conclusions.

The hidden cost of antibiotics: microbial dysbiosis-induced ...

grape powder effects 10% grape powder restored gut bacterial evenness; Antibiotics taken within the first year of life are linked to infant gut microbiome ...

Studies on Modulation of Gut Microbiota by Wine ...

polyphenol-rich grape products modified the gut morphology and intestinal microbiota and increased the degree of biodiversity in intestinal bacteria of broiler ...