Trials / Completed
CompletedNCT03934177
Impact of Blueberry Consumption on Gastrointestinal Health
Impact of Blueberry Consumption on Intestinal Permeability, Gut Microbiota, and Gut-Derived Inflammation in Individuals With Elevated Risk of a Pro-Inflammatory Gut Milieu
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- University of Nebraska Lincoln · Academic / Other
- Sex
- All
- Age
- 19 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Blueberry powder | Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart. |
| DIETARY_SUPPLEMENT | Placebo powder | A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart. |
Timeline
- Start date
- 2019-03-26
- Primary completion
- 2023-03-02
- Completion
- 2023-03-02
- First posted
- 2019-05-01
- Last updated
- 2023-03-22
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03934177. Inclusion in this directory is not an endorsement.