Status:
COMPLETED
Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
Lead Sponsor:
Louisiana State University, Baton Rouge
Collaborating Sponsors:
U.S. Highbush Blueberry Council
Louisiana Health Care Practitioners, LLC
Conditions:
Depression
Depression, Anxiety
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04398784
Start Date
April 15 2019
End Date
November 26 2019
Last Update
May 21 2020
Active Locations (2)
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1
Cottonport Family Clinic
Cottonport, Louisiana, United States, 71327
2
Marksville Family Clinic
Marksville, Louisiana, United States, 71351