Completed
NA
INTERVENTIONAL
NCT04398784
Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Freeze Dried Blueberry Powder - 71717
Type:
DIETARY_SUPPLEMENT
Description:
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.
Name:
USHBC Blueberry Placebo Formula #114
Type:
DIETARY_SUPPLEMENT
Description:
Blueberry flavor- and color-matched placebo powder.
Primary Outcomes
Measure:
Major Depression Inventory (MDI)
TimeFrame:
Day 1 of treatment intervention, before treatment consumption
Description:
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Measure:
Major Depression Inventory (MDI)
TimeFrame:
Day 30 of treatment intervention
Description:
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Measure:
Major Depression Inventory (MDI)
TimeFrame:
Day 60 of treatment intervention
Description:
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Measure:
Major Depression Inventory (MDI)
TimeFrame:
Day 1 of placebo intervention, before placebo consumption
Description:
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Measure:
Major Depression Inventory (MDI)
TimeFrame:
Day 30 of placebo intervention
Description:
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Measure:
Major Depression Inventory (MDI)
TimeFrame:
Day 60 of placebo intervention
Description:
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time, and 5=all the time; the higher the score, the more severe the depressive symptom.
Measure:
Generalized Anxiety Disorder 7-item (GAD-7) scale
TimeFrame:
Day 1 of treatment intervention, before treatment consumption
Description:
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Measure:
Generalized Anxiety Disorder 7-item (GAD-7) scale
TimeFrame:
Day 30 of treatment intervention
Description:
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Measure:
Generalized Anxiety Disorder 7-item (GAD-7) scale
TimeFrame:
Day 60 of treatment intervention
Description:
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Measure:
Generalized Anxiety Disorder 7-item (GAD-7) scale
TimeFrame:
Day 1 of placebo intervention, before placebo consumption
Description:
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Measure:
Generalized Anxiety Disorder 7-item (GAD-7) scale
TimeFrame:
Day 30 of placebo intervention
Description:
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Measure:
Generalized Anxiety Disorder 7-item (GAD-7) scale
TimeFrame:
Day 60 of placebo intervention
Description:
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Measure:
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
TimeFrame:
Day 1 of treatment intervention, before treatment consumption
Description:
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Measure:
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
TimeFrame:
Day 60 of treatment intervention
Description:
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Measure:
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
TimeFrame:
Day 1 of placebo intervention, before placebo consumption
Description:
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Measure:
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
TimeFrame:
Day 60 of placebo intervention
Description:
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Trial Information
NCT ID
NCT04398784
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Louisiana State University, Baton Rouge
Last Updated
December 15, 2025