- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03934177
Recruitment Status Enrolling by invitation
First Posted May 1, 2019
Last update posted February 21, 2021
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.
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 21 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.
|Experimental: Blueberry powder
4 weeks of supplementation of 21 g whole blueberry powder
Dietary Supplement: Blueberry powder
Dried, powdered blueberries will be consumed at 21 g/day in two divided doses at least 4 hours apart.
|Placebo Comparator: Placebo powder
4 weeks of supplementation of 21 g placebo powder (maltodextrin)
Dietary Supplement: Placebo powder
A placebo consisting maltodextrin will be consumed at 21 g/day in two divided doses at least 4 hours apart.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- obese (BMI +/- 30.0 kg/m2)
- shift workers (shift work overnight (third shift) +/= 3 days/week for the past 3
- 19-70 years of age
- 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
- 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.
United States, Nebraska
University of Nebraska
University of Nebraska Lincoln
Rush University Medical Center
Principal Investigator: Heather E Rasmussen, PhD University of Nebraska Lincoln