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

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.

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.

Eligibility Criteria:
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