Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
- Conditions
- DepressionInflammationDepression, Anxiety
- Interventions
- Dietary Supplement: Freeze Dried Blueberry Powder - 71717Dietary Supplement: USHBC Blueberry Placebo Formula #114
- Registration Number
- NCT04398784
- Lead Sponsor
- Louisiana State University, Baton Rouge
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1-Blueberry First/Placebo First Freeze Dried Blueberry Powder - 71717 Participants will be randomly assigned into either blueberry-first treatment or placebo-first group. 1-Blueberry First/Placebo First USHBC Blueberry Placebo Formula #114 Participants will be randomly assigned into either blueberry-first treatment or placebo-first group. 2-Crossover Freeze Dried Blueberry Powder - 71717 Participants who received blueberry treatment will switch to placebo and vice versa. 2-Crossover USHBC Blueberry Placebo Formula #114 Participants who received blueberry treatment will switch to placebo and vice versa.
- Primary Outcome Measures
Name Time Method Major Depression Inventory (MDI) Day 60 of placebo intervention 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.
Generalized Anxiety Disorder 7-item (GAD-7) scale Day 60 of placebo intervention 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.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC) Day 60 of placebo intervention 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.
- Secondary Outcome Measures
Name Time Method Concentration of tryptophan Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4) Day 1 of treatment intervention, before treatment consumption Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
CRP Measure Day 60 of placebo intervention Biological measure of C-Reactive Protein from participant blood sample
Concentration of reactive oxygen species (ROS) Day 60 of placebo intervention Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of kynurenine Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Gut Microbiome Analysis Day 60 of placebo intervention uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Concentration of quinolinic acid Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO) Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1) Day 1 of treatment intervention, before treatment consumption Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of glial cell line-derived neurotropic factor (GDNF) Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of serotonin related compound SERT Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA) Day 1 of treatment intervention, before treatment consumption Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of cortisol Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
C-Reactive Protein (CRP) Measure Immediately after enrollment, 30 days before start of intervention Biological measure of C-Reactive Protein from participant blood sample
Leeds Sleep Evaluation Questionnaire (LSEQ) Day 60 of placebo intervention 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.
Concentration of kynurenic acid Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2) Day 1 of treatment intervention, before treatment consumption Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2 Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of glutamate Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of suicide-associated protein SLC4A4 Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of serotonin related compound serotonin transporter (SERT) Day 1 of treatment intervention, before treatment consumption Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound 5-HIAA Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of glutamine Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma) Day 60 of placebo intervention Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of suicide-associated protein SAT-1 Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of brain-derived neurotropic factor (BDNF) Day 60 of placebo intervention Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of inflammation biomarker interleukin 6 (IL-6) Day 60 of placebo intervention Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta) Day 60 of placebo intervention Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha) Day 60 of placebo intervention Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Trial Locations
- Locations (2)
Marksville Family Clinic
🇺🇸Marksville, Louisiana, United States
Cottonport Family Clinic
🇺🇸Cottonport, Louisiana, United States