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
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 |
Verified date | March 2023 |
Source | University of Nebraska Lincoln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska | Lincoln | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska Lincoln | Rush University Medical Center, University of Nebraska |
United States,
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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