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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934177
Other study ID # 18557
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 26, 2019
Est. completion date March 2, 2023

Study information

Verified date March 2023
Source University of Nebraska Lincoln
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Blueberry powder
Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.
Placebo powder
A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.

Locations

Country Name City State
United States University of Nebraska Lincoln Nebraska
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (3)

Lead Sponsor Collaborator
University of Nebraska Lincoln Rush University Medical Center, University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary intestinal permeability urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose. 28 days
Secondary Microbiota Microbiota composition through shotgun sequencing. Composition includes relative abundance of all microbes in stool. 28 days
Secondary Microbial metabolites Quantity of stool short-chain fatty acid (butyrate, propionate, acetate) per dry stool weight by gas chromatography 28 days
Secondary Gut-derived/systemic inflammation Concentration of serum lipopolysaccharide (LPS), LPS-binding protein (LBP), and interleukin-6 (IL6) 28 days
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