Trials / Completed
CompletedNCT04398784
Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Louisiana State University, Baton Rouge · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This pilot study aims to measure the effects of an intervention of 22.5 grams of freeze-dried whole blueberry powder in water drunk daily. Measures are on outcomes of depression, biological markers of inflammation and oxidative stress, and microbial populations in the intestines.
Detailed description
A 29 week double-blind, placebo-controlled, crossover intervention assessing the effect of a blueberries on behavioral symptoms related to depression, biological markers of inflammation and oxidative stress, and gut microbiome measures. A total of 45 participants will be randomly assigned to either a blueberry-first or placebo-first group; participants will take 22.5 grams of either freeze-dried blueberry powder or matched placebo powder mixed with water daily for 12 weeks. This period is followed by a 4 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Freeze Dried Blueberry Powder - 71717 | Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption. |
| DIETARY_SUPPLEMENT | USHBC Blueberry Placebo Formula #114 | Blueberry flavor- and color-matched placebo powder. |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2019-11-26
- Completion
- 2019-11-26
- First posted
- 2020-05-21
- Last updated
- 2020-05-21
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04398784. Inclusion in this directory is not an endorsement.