Back to resultsImpact of Blueberry Consumption on Gastrointestinal Health
Primary Purpose
Obesity, Circadian Dysregulation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry powder
Placebo powder
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Blueberry, Microbiota, Intestinal permeability
Eligibility Criteria
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.
Sites / Locations
- University of Nebraska
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Blueberry powder
Placebo powder
Arm Description
4 weeks of supplementation of 24 g whole blueberry powder
4 weeks of supplementation of 24 g placebo powder (maltodextrin)
Outcomes
Primary Outcome Measures
intestinal permeability
urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose.
Secondary Outcome Measures
Microbiota
Microbiota composition through shotgun sequencing. Composition includes relative abundance of all microbes in stool.
Microbial metabolites
Quantity of stool short-chain fatty acid (butyrate, propionate, acetate) per dry stool weight by gas chromatography
Gut-derived/systemic inflammation
Concentration of serum lipopolysaccharide (LPS), LPS-binding protein (LBP), and interleukin-6 (IL6)
Full Information
NCT ID
NCT03934177
First Posted
April 15, 2019
Last Updated
March 20, 2023
Sponsor
University of Nebraska Lincoln
Collaborators
Rush University Medical Center, University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT03934177
Brief Title
Impact of Blueberry Consumption on Gastrointestinal Health
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln
Collaborators
Rush University Medical Center, University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Circadian Dysregulation
Keywords
Blueberry, Microbiota, Intestinal permeability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This 14-week crossover study includes 4 weeks for each of the two supplementation periods (blueberries and placebo), with a 4-week wash out between.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, investigators, and statistician will blinded to treatment.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blueberry powder
Arm Type
Experimental
Arm Description
4 weeks of supplementation of 24 g whole blueberry powder
Arm Title
Placebo powder
Arm Type
Placebo Comparator
Arm Description
4 weeks of supplementation of 24 g placebo powder (maltodextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry powder
Intervention Description
Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo powder
Intervention Description
A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.
Primary Outcome Measure Information:
Title
intestinal permeability
Description
urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Microbiota
Description
Microbiota composition through shotgun sequencing. Composition includes relative abundance of all microbes in stool.
Time Frame
28 days
Title
Microbial metabolites
Description
Quantity of stool short-chain fatty acid (butyrate, propionate, acetate) per dry stool weight by gas chromatography
Time Frame
28 days
Title
Gut-derived/systemic inflammation
Description
Concentration of serum lipopolysaccharide (LPS), LPS-binding protein (LBP), and interleukin-6 (IL6)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather E Rasmussen, PhD
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Blueberry Consumption on Gastrointestinal Health
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