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
Lead SponsorLouisiana State University
StatusCompleted No Results Posted
Intervention/TreatmentFreeze Dried Blueberry Powder - 71717 ...
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.
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.
Blueberry flavor- and color-matched placebo powder.
Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.
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