Impact of Blueberry Consumption on Gastrointestinal Health

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934177
• Other study ID #: 18557
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Obesity

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