125 Participants NeededMy employer runs this trial

Blueberry Beverage for Microbiome Analysis

(BlueBIOME Trial)

JW
TW
Overseen ByTiffany Weir, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals' gut bacteria affect nutrient processing from blueberries. Participants will consume a special blueberry beverage made from freeze-dried blueberry powder, and researchers will study nutrient absorption and utilization in their bodies. The goal is to determine if gut bacteria can predict these differences. The trial seeks healthy adults willing to follow study guidelines and without chronic diseases that might affect the results. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on nutrition and gut health.

Will I have to stop taking my current medications?

If you are taking medications for chronic diseases, you may need to stop as they could interfere with the study outcomes. The trial does not specify other medication restrictions.

What prior data suggests that this blueberry beverage is safe?

Research has shown that freeze-dried blueberry powder is generally safe for consumption. In several studies, participants regularly consumed blueberry powder without major side effects. For instance, one study found that people who drank a blueberry powder drink for six weeks experienced no serious problems, indicating safety for most individuals.

Another study, where participants consumed blueberry powder daily, reported similar results, with no serious safety issues. Instead, these studies highlighted positive effects, such as improvements in gut health and overall well-being.

These findings suggest that drinking a blueberry powder beverage is safe and unlikely to cause harm. However, as with any new dietary change, consulting a healthcare provider is wise, especially if specific health concerns exist.12345

Why are researchers excited about this trial?

Researchers are excited about the freeze-dried blueberry powder beverage because it offers a natural approach to enhancing gut health by analyzing microbiome changes. Unlike standard treatments that might involve probiotics or dietary changes, this beverage is packed with polyphenol metabolites, which are plant compounds known for their antioxidant properties. The unique feature of this treatment is its potential to improve gut health by introducing these powerful plant compounds in a simple, single-dose format, making it both convenient and potentially more effective in modulating the gut microbiome.

What evidence suggests that this blueberry beverage is effective for microbiome analysis?

Studies have shown that blueberry powder benefits gut health. Research indicates that consuming a moderate amount can increase beneficial gut bacteria, such as Bifidobacteria. One study found that an 8-week regimen of freeze-dried blueberry supplements affected immune system pathways linked to gut health. Animal studies also suggest that blueberries promote the growth of beneficial bacteria and enhance gut function. These findings support the idea that blueberry powder may help balance the gut microbiome, potentially improving overall gut health. In this trial, all participants will receive a single dose of the freeze-dried blueberry powder beverage to characterize the pharmacokinetic profiles of polyphenol metabolites.36789

Are You a Good Fit for This Trial?

This trial is for adults who are generally healthy and interested in how their gut bacteria affect the way their bodies process blueberry compounds. Specific inclusion or exclusion criteria are not listed, but participants should not have major health issues.

Inclusion Criteria

I am a healthy adult who is 18 years old or older.
Willing and able to adhere to all study procedures and visit requirements
Able and willing to provide informed consent

Exclusion Criteria

I am under 18 years old.
Recent blood draw within 1 week prior to study participation
Currently participating in another research study involving a diet or exercise intervention
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Lead-in Period

Participants collect stool and urine samples at home and follow a low-polyphenol diet for three days

3 days

Acute Test Day

Participants consume a standardized blueberry beverage and undergo serial blood sampling to assess pharmacokinetics

1 day
1 visit (in-person)

Follow-up

Participants return for a follow-up visit to provide additional biological samples

24 hours post-consumption
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Freeze-dried blueberry powder beverage

Trial Overview

The study tests how drinking a freeze-dried blueberry powder beverage affects levels of certain blueberry-related substances in the body, and whether differences in gut bacteria explain these effects. Participants' metabolite profiles will be analyzed after consuming blueberries.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single-armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

King's College London

Collaborator

Trials
772
Recruited
26,130,000+

Florida State University

Collaborator

Trials
234
Recruited
41,100+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Citations

Introducing blueberry powder as one of the first ... - PMC

Animal studies indicate that blueberry consumption can promote the growth of commensals (13) and restore impaired gut integrity (14).

Effects of Blueberry on Gut Microbiota and Metabolic ...

An 8-week freeze-dried blueberry supplement impacts immune-related pathways: a randomized, double-blind placebo-controlled trial.

Assess the Effect of a Whole Fruit Powder on Gut Microbiome ...

The goal of this clinical trial is to evaluate the effect of freeze-dried blueberry powder on the gut microbiome in overweight and obese adults.

Moderate consumption of freeze-dried blueberry powder ...

Moderate consumption of freeze-dried blueberry powder increased net bone calcium retention compared with no treatment in healthy postmenopausal women: Moderate ...

Blueberry Powder for Depression · Info for Participants

The study tests if consuming freeze-dried blueberry powder daily affects gut health and eases depressive symptoms compared to a placebo in inactive older adults ...

Effects of Blueberry Consumption on Fecal Microbiome ... - PMC

A diet enhanced with blueberry or placebo powder was associated with changes in circulating biomarkers, including the gut microbiome-related metabolites.

Six-Week Consumption of a Wild Blueberry Powder Drink ...

Wild blueberries are a rich source of polyphenols and other compounds that are highly metabolized by the intestinal microbiota and may, at the same time, ...

Introducing blueberry powder as one of the first ...

This was a double-blind, randomized, placebo-controlled feeding trial examining the effects of daily freeze-dried blueberry powder consumption on gut microbiota ...

Blueberries and Your Gut: How a Daily Berry Habit ...

These findings suggest that blueberries target specific beneficial gut bacteria, offering unique advantages when combined with exercise.