Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population

May 18, 2020 updated by: Joseph Francis, Ph.D, Louisiana State University, Baton Rouge

Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Louisiana
  - Cottonport, Louisiana, United States, 71327
    - Cottonport Family Clinic
  - Marksville, Louisiana, United States, 71351
    - Marksville Family Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants with a stable diagnosis of Major Depressive Disorder (>1 year prior to enrollment)
Males and females 18-70 years of age
Subjects with sleep disruptions
Subjects currently prescribed to a non-antipsychotic mono-pharmacotherapies
English speaking subjects only (all evaluations are in English)

Subjects with the following inflammatory disorders that exhibit low to moderate symptoms:

Hypertension (mild=140/80-160/90; moderate= 160/90-180/100)
Asthma (requiring 2 or fewer inhalations of rescue inhaler per day)
Gastroesophageal reflux disease
Irritable bowel syndrome (controlled, <3 bowel movements a day)
Arthritis (controlled)
Chronic stomach ulcers (controlled)
Obesity BMI <40
Chronic pain
Fibromyalgia
Chronic Fatigue Syndrome
Type I or Type II diabetes (controlled)
Subjects that are compliant with current treatment regimens and clinic appointments
Subjects taking intermittent or infrequent doses of acetaminophen or NSAIDs
Subjects who currently smoke or have a history of smoking

Exclusion Criteria:

Subjects with current diagnosis or history of the following conditions; or subjects currently on medication for any of the following conditions:

Severe Cardiovascular disease; Heart attack/pacemaker
Cancer
Autoimmunity Disorders
Crohn's Disease or Ulcerative Colitis
Alzheimer's Disease
Parkinson's Disease
Multiple Sclerosis
Uncontrolled Diabetes: Type I or II
Severe irritable bowel disease (>3 stools per day)
Hypertension (severe >180/100)
Hypotension (<100/60)
Epilepsy
Autism Spectrum Disorder
Schizophrenia
Psychosis/Psychotic Symptoms
Uncontrolled Hypo/Hyperthyroidism
Women who are pregnant, nursing, lactating, or planning to become pregnant within timeline of study
Subjects who are blind or deaf
Subjects who are allergic to blueberries or other similar foods or drinks (e.g. wine), or subjects who are allergic to red or blue food dye agents
Subjects who do not like the taste of blueberries
Subjects who do not want to disclose information related to their Major Depressive Disorder
Subjects who do not want to be subjected to blood draws
Subjects who consume >4 cups of blueberries per week or other foods/drinks with significant polyphenol content
Subjects supplementing with elderberry syrup >4 times per week
Subjects who have a planned surgery during the timeline of the study
Subjects prescribed to antipsychotics
Subjects using acetaminophen or NSAIDS (drugs targeting pro-inflammatory paths) chronically or exceeding recommended daily doses
Subjects chronically on Decadron, Dexamethasone, or Prednisone; or other oral steroids
Subjects on any augmenting agents (the following is not an inclusive list):

Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Clozaril(clozapine), Symbyax (olanzapine/fluoxetine), Geodon (ziprasidone)

Subjects supplementing with devil's claw, fenugreek, guar gum, Panax ginseng, and Siberian ginseng
Subjects who have a history of suicidal ideation or suicide attempt
Subjects with a history or record of physical violence toward self or others
Subjects who will jeopardize their job if they miss work for appointments
Subjects with a history of addiction, except cigarettes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1-Blueberry First/Placebo First Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.	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. Other Names: Tifblue/Rubel 50/50 Blend Dietary supplement: USHBC Blueberry Placebo Formula #114 Blueberry flavor- and color-matched placebo powder.
Other: 2-Crossover Participants who received blueberry treatment will switch to placebo and vice versa.	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. Other Names: Tifblue/Rubel 50/50 Blend Dietary supplement: USHBC Blueberry Placebo Formula #114 Blueberry flavor- and color-matched placebo powder.

Participant Group / Arm

Intervention / Treatment

Other: 1-Blueberry First/Placebo First

Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.

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.

Other Names:

Tifblue/Rubel 50/50 Blend

Dietary supplement: USHBC Blueberry Placebo Formula #114

Blueberry flavor- and color-matched placebo powder.

Other: 2-Crossover

Participants who received blueberry treatment will switch to placebo and vice versa.

Dietary supplement: Freeze Dried Blueberry Powder - 71717

Other Names:

Tifblue/Rubel 50/50 Blend

Dietary supplement: USHBC Blueberry Placebo Formula #114

Blueberry flavor- and color-matched placebo powder.

What is the study measuring?

Primary Outcome Measures

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University, Baton Rouge

Collaborators

U.S. Highbush Blueberry Council

Louisiana Health Care Practitioners, LLC

Collective Healthcare Solutions, LLC

uBiome, Inc.

Investigators

Principal Investigator: Joseph Francis, Ph.D., Louisiana State University, Baton Rouge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

November 26, 2019

Study Completion (Actual)

November 26, 2019

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

46680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
Major Depression Inventory (MDI) Time Frame: Day 1 of treatment intervention, before treatment consumption	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.	Day 1 of treatment intervention, before treatment consumption
Major Depression Inventory (MDI) Time Frame: Day 30 of treatment intervention	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.	Day 30 of treatment intervention
Major Depression Inventory (MDI) Time Frame: Day 60 of treatment intervention	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.	Day 60 of treatment intervention
Major Depression Inventory (MDI) Time Frame: Day 1 of placebo intervention, before placebo consumption	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.	Day 1 of placebo intervention, before placebo consumption
Major Depression Inventory (MDI) Time Frame: Day 30 of placebo intervention	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.	Day 30 of placebo intervention
Major Depression Inventory (MDI) Time Frame: Day 60 of placebo intervention	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.	Day 60 of placebo intervention
Generalized Anxiety Disorder 7-item (GAD-7) scale Time Frame: Day 1 of treatment intervention, before treatment consumption	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.	Day 1 of treatment intervention, before treatment consumption
Generalized Anxiety Disorder 7-item (GAD-7) scale Time Frame: Day 30 of treatment intervention	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.	Day 30 of treatment intervention
Generalized Anxiety Disorder 7-item (GAD-7) scale Time Frame: Day 60 of treatment intervention	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.	Day 60 of treatment intervention
Generalized Anxiety Disorder 7-item (GAD-7) scale Time Frame: Day 1 of placebo intervention, before placebo consumption	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.	Day 1 of placebo intervention, before placebo consumption
Generalized Anxiety Disorder 7-item (GAD-7) scale Time Frame: Day 30 of placebo intervention	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.	Day 30 of placebo intervention
Generalized Anxiety Disorder 7-item (GAD-7) scale Time Frame: Day 60 of placebo intervention	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.	Day 60 of placebo intervention
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) Time Frame: Day 1 of treatment intervention, before treatment consumption	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.	Day 1 of treatment intervention, before treatment consumption
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) Time Frame: Day 60 of treatment intervention	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.	Day 60 of treatment intervention
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) Time Frame: Day 1 of placebo intervention, before placebo consumption	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.	Day 1 of placebo intervention, before placebo consumption
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) Time Frame: Day 60 of placebo intervention	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.	Day 60 of placebo intervention

Outcome Measure	Measure Description	Time Frame
C-Reactive Protein (CRP) Measure Time Frame: Immediately after enrollment, 30 days before start of intervention	Biological measure of C-Reactive Protein from participant blood sample	Immediately after enrollment, 30 days before start of intervention
CRP Measure Time Frame: Day 1 of treatment intervention, before treatment consumption	Biological measure of C-Reactive Protein from participant blood sample	Day 1 of treatment intervention, before treatment consumption
CRP Measure Time Frame: Day 30 of treatment intervention	Biological measure of C-Reactive Protein from participant blood sample	Day 30 of treatment intervention
CRP Measure Time Frame: Day 60 of treatment intervention	Biological measure of C-Reactive Protein from participant blood sample	Day 60 of treatment intervention
CRP Measure Time Frame: Day 1 of placebo intervention, before placebo consumption	Biological measure of C-Reactive Protein from participant blood sample	Day 1 of placebo intervention, before placebo consumption
CRP Measure Time Frame: Day 30 of placebo intervention	Biological measure of C-Reactive Protein from participant blood sample	Day 30 of placebo intervention
CRP Measure Time Frame: Day 60 of placebo intervention	Biological measure of C-Reactive Protein from participant blood sample	Day 60 of placebo intervention
Gut Microbiome Analysis Time Frame: Day 1 of treatment intervention, before treatment consumption	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 1 of treatment intervention, before treatment consumption
Gut Microbiome Analysis Time Frame: Day 30 of treatment intervention	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 30 of treatment intervention
Gut Microbiome Analysis Time Frame: Day 60 of treatment intervention	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 60 of treatment intervention
Gut Microbiome Analysis Time Frame: Day 1 of placebo intervention, before placebo consumption	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 1 of placebo intervention, before placebo consumption
Gut Microbiome Analysis Time Frame: Day 30 of placebo intervention	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 30 of placebo intervention
Gut Microbiome Analysis Time Frame: Day 60 of placebo intervention	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 60 of placebo intervention
Leeds Sleep Evaluation Questionnaire (LSEQ) Time Frame: Day 1 of treatment intervention, before treatment consumption	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 1 of treatment intervention, before treatment consumption
Leeds Sleep Evaluation Questionnaire (LSEQ) Time Frame: Day 30 of treatment intervention	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 30 of treatment intervention
Leeds Sleep Evaluation Questionnaire (LSEQ) Time Frame: Day 60 of treatment intervention	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 60 of treatment intervention
Leeds Sleep Evaluation Questionnaire (LSEQ) Time Frame: Day 1 of placebo intervention, before placebo consumption	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 1 of placebo intervention, before placebo consumption
Leeds Sleep Evaluation Questionnaire (LSEQ) Time Frame: Day 30 of placebo intervention	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 30 of placebo intervention
Leeds Sleep Evaluation Questionnaire (LSEQ) Time Frame: Day 60 of placebo intervention	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 60 of placebo intervention
Concentration of reactive oxygen species (ROS) Time Frame: Day 1 of treatment intervention, before treatment consumption	Electron paramagnetic resonance (EPR) to measures reactive oxygen species (ROS) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Concentration of reactive oxygen species (ROS) Time Frame: Day 30 of treatment intervention	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 30 of treatment intervention
Concentration of reactive oxygen species (ROS) Time Frame: Day 60 of treatment intervention	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 60 of treatment intervention
Concentration of reactive oxygen species (ROS) Time Frame: Day 1 of placebo intervention, before placebo consumption	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Concentration of reactive oxygen species (ROS) Time Frame: Day 30 of placebo intervention	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 30 of placebo intervention
Concentration of reactive oxygen species (ROS) Time Frame: Day 60 of placebo intervention	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 60 of placebo intervention
Concentration of quinolinic acid Time Frame: Day 1 of treatment intervention, before treatment consumption	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Concentration of quinolinic acid Time Frame: Day 30 of treatment intervention	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 30 of treatment intervention
Concentration of quinolinic acid Time Frame: Day 60 of treatment intervention	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 60 of treatment intervention
Concentration of quinolinic acid Time Frame: Day 1 of placebo intervention, before placebo consumption	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Concentration of quinolinic acid Time Frame: Day 30 of placebo intervention	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 30 of placebo intervention
Concentration of quinolinic acid Time Frame: Day 60 of placebo intervention	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 60 of placebo intervention
Concentration of kynurenic acid Time Frame: Day 1 of treatment intervention, before treatment consumption	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Concentration of kynurenic acid Time Frame: Day 30 of treatment intervention	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 30 of treatment intervention
Concentration of kynurenic acid Time Frame: Day 60 of treatment intervention	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 60 of treatment intervention
Concentration of kynurenic acid Time Frame: Day 1 of placebo intervention, before placebo consumption	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Concentration of kynurenic acid Time Frame: Day 30 of placebo intervention	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 30 of placebo intervention
Concentration of kynurenic acid Time Frame: Day 60 of placebo intervention	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 60 of placebo intervention
Concentration of kynurenine Time Frame: Day 1 of treatment intervention, before treatment consumption	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Concentration of kynurenine Time Frame: Day 30 of treatment intervention	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 30 of treatment intervention
Concentration of kynurenine Time Frame: Day 60 of treatment intervention	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 60 of treatment intervention

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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