Trial | NCT04398784  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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.
Study Started
Apr 15
2019
Primary Completion
Nov 26
2019
Study Completion
Nov 26
2019
Last Update
May 21
2020

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.

1-Blueberry First/Placebo First Other

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

2-Crossover Other

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

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
No Results Posted