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

Louisiana State University, Baton Rouge

Status: Completed

Conditions: Inflammation; Depression, Anxiety; Depression

Treatments: Dietary Supplement: Freeze Dried Blueberry Powder - 71717; Dietary Supplement: USHBC Blueberry Placebo Formula #114

Study type: Interventional

Funder types: Other

Identifiers

NCT04398784

46680

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

1-Blueberry First/Placebo First

Other group

Description:

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

Treatment:

Dietary Supplement: USHBC Blueberry Placebo Formula #114

Dietary Supplement: Freeze Dried Blueberry Powder - 71717

2-Crossover

Other group

Description:

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

Treatment:

Dietary Supplement: USHBC Blueberry Placebo Formula #114

Dietary Supplement: Freeze Dried Blueberry Powder - 71717