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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Depression, Anxiety, Inflammation

Intervention / Treatment
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* Dietary Supplement: Freeze Dried Blueberry Powder - 71717
* Dietary Supplement: USHBC Blueberry Placebo Formula #114


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study will utilize a randomized, double-blind, placebo-controlled, crossover design. 60 participants with depression will be randomized into either the placebo first or blueberry first group. Randomization will be based on outcomes from behavioral measures (Major Depression Inventory and GAD-7) and a physiological measure (C-reactive protein levels) in appointment 0. The first arm will consist of 12 weeks of daily treatment and baseline (pre-intervention), mid-intervention and post-intervention assessments. Next there will be a four week washout period, after which patients will switch treatments, and the second arm will commence--identical to the first in structure. Further, the study is a repeated measures design with each participant's baseline measures serving as her or his own control.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1-Blueberry First/Placebo First<br>Participants will be randomly assigned into either blueberry-first treatment or placebo-first group. | Dietary Supplement: Freeze Dried Blueberry Powder - 71717<br>* 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.<br>* Other names: Tifblue/Rubel 50/50 Blend;Dietary Supplement: USHBC Blueberry Placebo Formula #114<br>* Blueberry flavor- and color-matched placebo powder.<br>|
| Other: 2-Crossover<br>Participants who received blueberry treatment will switch to placebo and vice versa. | Dietary Supplement: Freeze Dried Blueberry Powder - 71717<br>* 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.<br>* Other names: Tifblue/Rubel 50/50 Blend;Dietary Supplement: USHBC Blueberry Placebo Formula #114<br>* Blueberry flavor- and color-matched placebo powder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Depression Inventory (MDI) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein (CRP) Measure | Biological measure of C-Reactive Protein from participant blood sample | Immediately after enrollment, 30 days before start of intervention | 
| CRP Measure | Biological measure of C-Reactive Protein from participant blood sample | Day 1 of treatment intervention, before treatment consumption | 
| CRP Measure | Biological measure of C-Reactive Protein from participant blood sample | Day 30 of treatment intervention | 
| CRP Measure | Biological measure of C-Reactive Protein from participant blood sample | Day 60 of treatment intervention | 
| CRP Measure | Biological measure of C-Reactive Protein from participant blood sample | Day 1 of placebo intervention, before placebo consumption | 
| CRP Measure | Biological measure of C-Reactive Protein from participant blood sample | Day 30 of placebo intervention | 
| CRP Measure | Biological measure of C-Reactive Protein from participant blood sample | Day 60 of placebo intervention | 
| Gut Microbiome Analysis | 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 | uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome | Day 30 of treatment intervention | 
| Gut Microbiome Analysis | uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome | Day 60 of treatment intervention | 
| Gut Microbiome Analysis | 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 | uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome | Day 30 of placebo intervention | 
| Gut Microbiome Analysis | uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome | Day 60 of placebo intervention | 
| Leeds Sleep Evaluation Questionnaire (LSEQ) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of reactive oxygen species (ROS) | Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of reactive oxygen species (ROS) | 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) | Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of reactive oxygen species (ROS) | Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples | Day 60 of placebo intervention | 
| Concentration of quinolinic acid | 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 | Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples | Day 30 of treatment intervention | 
| Concentration of quinolinic acid | Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples | Day 60 of treatment intervention | 
| Concentration of quinolinic acid | 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 | Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples | Day 30 of placebo intervention | 
| Concentration of quinolinic acid | Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples | Day 60 of placebo intervention | 
| Concentration of kynurenic acid | 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 | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples | Day 30 of treatment intervention | 
| Concentration of kynurenic acid | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples | Day 60 of treatment intervention | 
| Concentration of kynurenic acid | 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 | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples | Day 30 of placebo intervention | 
| Concentration of kynurenic acid | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples | Day 60 of placebo intervention | 
| Concentration of kynurenine | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of kynurenine | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples | Day 30 of treatment intervention | 
| Concentration of kynurenine | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples | Day 60 of treatment intervention | 
| Concentration of kynurenine | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of kynurenine | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples | Day 30 of placebo intervention | 
| Concentration of kynurenine | Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples | Day 60 of placebo intervention | 
| Concentration of tryptophan | Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of tryptophan | Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples | Day 30 of treatment intervention | 
| Concentration of tryptophan | Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples | Day 60 of treatment intervention | 
| Concentration of tryptophan | Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of tryptophan | Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples | Day 30 of placebo intervention | 
| Concentration of tryptophan | Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples | Day 60 of placebo intervention | 
| Concentration of indoleamine 2,3-dioxygenase (IDO) | Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of indoleamine 2,3-dioxygenase (IDO) | Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of indoleamine 2,3-dioxygenase (IDO) | Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of indoleamine 2,3-dioxygenase (IDO) | Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of indoleamine 2,3-dioxygenase (IDO) | Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of indoleamine 2,3-dioxygenase (IDO) | Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples | Day 60 of placebo intervention | 
| Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2) | Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of suicide-associated protein SKA-2 | Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples | Day 30 of treatment intervention | 
| Concentration of suicide-associated protein SKA-2 | Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples | Day 60 of treatment intervention | 
| Concentration of suicide-associated protein SKA-2 | Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of suicide-associated protein SKA-2 | Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples | Day 30 of placebo intervention | 
| Concentration of suicide-associated protein SKA-2 | Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples | Day 60 of placebo intervention | 
| Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1) | Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of suicide-associated protein SAT-1 | Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples | Day 30 of treatment intervention | 
| Concentration of suicide-associated protein SAT-1 | Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples | Day 60 of treatment intervention | 
| Concentration of suicide-associated protein SAT-1 | Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of suicide-associated protein SAT-1 | Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples | Day 30 of placebo intervention | 
| Concentration of suicide-associated protein SAT-1 | Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples | Day 60 of placebo intervention | 
| Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4) | Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of suicide-associated protein SLC4A4 | Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples | Day 30 of treatment intervention | 
| Concentration of suicide-associated protein SLC4A4 | Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples | Day 60 of treatment intervention | 
| Concentration of suicide-associated protein SLC4A4 | Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of suicide-associated protein SLC4A4 | Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples | Day 30 of placebo intervention | 
| Concentration of suicide-associated protein SLC4A4 | Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples | Day 60 of placebo intervention | 
| Concentration of brain-derived neurotropic factor (BDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of brain-derived neurotropic factor (BDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples | Day 30 of treatment intervention | 
| Concentration of brain-derived neurotropic factor (BDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples | Day 60 of treatment intervention | 
| Concentration of brain-derived neurotropic factor (BDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of brain-derived neurotropic factor (BDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples | Day 30 of placebo intervention | 
| Concentration of brain-derived neurotropic factor (BDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples | Day 60 of placebo intervention | 
| Concentration of glial cell line-derived neurotropic factor (GDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of glial cell line-derived neurotropic factor (GDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples | Day 30 of treatment intervention | 
| Concentration of glial cell line-derived neurotropic factor (GDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples | Day 60 of treatment intervention | 
| Concentration of glial cell line-derived neurotropic factor (GDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples | Day 1 of placebo intervention, before placebo intervention | 
| Concentration of glial cell line-derived neurotropic factor (GDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples | Day 30 of placebo intervention | 
| Concentration of glial cell line-derived neurotropic factor (GDNF) | Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples | Day 60 of placebo intervention | 
| Concentration of serotonin related compound serotonin transporter (SERT) | Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of serotonin related compound SERT | Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of serotonin related compound SERT | Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of serotonin related compound SERT | Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of serotonin related compound SERT | Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of serotonin related compound SERT | Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples | Day 60 of placebo intervention | 
| Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA) | Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of serotonin related compound 5-HIAA | Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of serotonin related compound 5-HIAA | Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of serotonin related compound 5-HIAA | Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of serotonin related compound 5-HIAA | Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of serotonin related compound 5-HIAA | Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples | Day 60 of placebo intervention | 
| Concentration of glutamate | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of glutamate | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples | Day 30 of treatment intervention | 
| Concentration of glutamate | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples | Day 60 of treatment intervention | 
| Concentration of glutamate | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of glutamate | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples | Day 30 of placebo intervention | 
| Concentration of glutamate | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples | Day 60 of placebo intervention | 
| Concentration of glutamine | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of glutamine | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples | Day 30 of treatment intervention | 
| Concentration of glutamine | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples | Day 60 of treatment intervention | 
| Concentration of glutamine | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of glutamine | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples | Day 30 of placebo intervention | 
| Concentration of glutamine | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples | Day 60 of placebo intervention | 
| Concentration of cortisol | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of cortisol | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples | Day 30 of treatment intervention | 
| Concentration of cortisol | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples | Day 60 of treatment intervention | 
| Concentration of cortisol | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of cortisol | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples | Day 30 of placebo intervention | 
| Concentration of cortisol | Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples | Day 60 of placebo intervention | 
| Concentration of inflammation biomarker interleukin 6 (IL-6) | Luminex assay to measure interleukin 6 (IL-6) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of inflammation biomarker interleukin 6 (IL-6) | Luminex assay to measure interleukin 6 (IL-6) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of inflammation biomarker interleukin 6 (IL-6) | Luminex assay to measure interleukin 6 (IL-6) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of inflammation biomarker interleukin 6 (IL-6) | Luminex assay to measure interleukin 6 (IL-6) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of inflammation biomarker interleukin 6 (IL-6) | Luminex assay to measure interleukin 6 (IL-6) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of inflammation biomarker interleukin 6 (IL-6) | Luminex assay to measure interleukin 6 (IL-6) in participant blood samples | Day 60 of placebo intervention | 
| Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) | Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) | Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) | Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) | Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) | Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) | Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples | Day 60 of placebo intervention | 
| Concentration of inflammation biomarker interferon gamma (IFN-gamma) | Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of inflammation biomarker interferon gamma (IFN-gamma) | Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of inflammation biomarker interferon gamma (IFN-gamma) | Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of inflammation biomarker interferon gamma (IFN-gamma) | Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of inflammation biomarker interferon gamma (IFN-gamma) | Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of inflammation biomarker interferon gamma (IFN-gamma) | Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples | Day 60 of placebo intervention | 
| Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) | Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples | Day 1 of treatment intervention, before treatment consumption | 
| Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) | Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples | Day 30 of treatment intervention | 
| Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) | Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples | Day 60 of treatment intervention | 
| Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) | Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples | Day 1 of placebo intervention, before placebo consumption | 
| Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) | Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples | Day 30 of placebo intervention | 
| Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) | Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples | Day 60 of placebo intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, inflammation, anxiety, blueberries