Impact of Blueberry Consumption on Gastrointestinal Health

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Circadian Dysregulation

In brief

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.

Key facts

Study ID

NCT03934177

Run by

University of Nebraska Lincoln

People needed

28

Starts

2019-03-26

Expected to finish

2023-03-02

Last updated by the study team

2023-03-22

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Nebraska — Lincoln, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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