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Completed

NCT Number: NCT03934177

Impact of Blueberry Consumption on Gastrointestinal Health

This study will evaluate the impact of blueberry consumption on markers of gastrointestinal health including gut microbiota, intestinal permeability, and gut-derived inflammation in those vulnerable to a unhealthy gut milieu. All participants will consume a blueberry powder and a placebo in this crossover study.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska, Lincoln, Nebraska, United States

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About this study

The commensal bacteria that reside in the human gut, known as the gut microbiota, is a complex system that modulates local gut homeostasis and systemic biological processes. Several environmental factors have been shown to influence the gut milieu (including microbiota), and thus both gastrointestinal and host health. Relevant to the current proposal is the influence of body weight, diet, and circadian rhythms. In the current study, the investigators propose to use these common disruptors of gastrointestinal health through recruiting obese shift workers with a low-fiber diet to identify if these disrupted individuals can benefit from blueberry intake. Specifically, the study objectives are to determine if 24 g whole blueberry powder consumed daily can beneficially modify intestinal permeability, gut microbiota, microbial metabolites, and both gut-derived and systemic inflammation in those most susceptible to a pro-inflammatory milieu. This will be accomplished through a 14-week crossover study in which 28 individuals will be randomized by treatment group order to 4 weeks of whole blueberry powder and placebo powder, with a 4-week wash out in between the treatment periods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese (BMI +/- 30.0 kg/m2)
  • shift workers (shift work overnight (third shift) +/= 3 days/week for the past 3 months)
  • 19-70 years of age

Exclusion criteria

  • patient history of gastrointestinal diseases except for hiatal hernia, GERD, or hemorrhoids, mild gastrointestinal symptoms
  • elevated laboratory values from a comprehensive metabolic panel (CMP) and complete blood count (CBC) with the exception of glucose (+/= 126 mg/dL; if elevated, confirmed with HA1c of greater than or equal to 6.5%) and ALT, AST, or ALP over 2 times normal levels (to allow for mild elevations resulting from fatty liver often seen in obese) unless approved by study physician
  • currently pregnant or plans to become pregnant during the study as determined by participant report
  • antibiotic use within the last 12 weeks prior to enrollment
  • presence of chronic metabolic disease (e.g., cardiovascular disease, diabetes, cancer) or per physician discretion
  • recent (past 4 weeks) major change in dietary habits or a plan to have a major change in dietary habits during the study
  • habitual blueberry consumption of more than 0.5 cups 2x/week or a 4-week washout period if consumes
  • allergy or intolerance to blueberries
  • consumption of supplemental fiber, probiotics or prebiotics without an appropriate 4-week washout period
  • restrictive dietary patterns (e.g., ketogenic, Paleolithic) or a diet high in fiber (+/= 14 g/1000 kilocalories) to increase study result generalizability to the U.S. population (low-fiber diet), as well as provide another stimuli for gut leakiness
  • unwillingness to consent to the study.

Treatment and study plan

Blueberry powder

Dietary Supplement

Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.

Placebo Powder

Dietary Supplement

A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.

Primary outcomes

  1. intestinal permeability

    Time frame: 28 days

    urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose.

Secondary outcomes

  1. Microbiota

    Time frame: 28 days

    Microbiota composition through shotgun sequencing. Composition includes relative abundance of all microbes in stool.

  2. Microbial metabolites

    Time frame: 28 days

    Quantity of stool short-chain fatty acid (butyrate, propionate, acetate) per dry stool weight by gas chromatography

  3. Gut-derived/systemic inflammation

    Time frame: 28 days

    Concentration of serum lipopolysaccharide (LPS), LPS-binding protein (LBP), and interleukin-6 (IL6)

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Collaborators

  • Rush University Medical Center
  • University of Nebraska

Registry information

Official study title

Impact of Blueberry Consumption on Intestinal Permeability, Gut Microbiota, and Gut-Derived Inflammation in Individuals With Elevated Risk of a Pro-Inflammatory Gut Milieu

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 1, 2019
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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