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

NCT04398784 | Completed

• 1 other identifier: 46680
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Depression, Anxiety; Inflammation

Keywords

depression; inflammation; anxiety; blueberries

Outcome Measures

Primary Outcomes (16)

• Major Depression Inventory (MDI)

  A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (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.

  Day 1 of treatment intervention, before treatment consumption

• Major Depression Inventory (MDI)

  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.

  Day 30 of treatment intervention

• Major Depression Inventory (MDI)

  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.

  Day 60 of treatment intervention

• Major Depression Inventory (MDI)

  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.

  Day 1 of placebo intervention, before placebo consumption

• Major Depression Inventory (MDI)

  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.

  Day 30 of placebo intervention

• Major Depression Inventory (MDI)

  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.

  Day 60 of placebo intervention

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  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.

  Day 1 of treatment intervention, before treatment consumption

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  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.

  Day 30 of treatment intervention

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  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.

  Day 60 of treatment intervention

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  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.

  Day 1 of placebo intervention, before placebo consumption

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  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.

  Day 30 of placebo intervention

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  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.

  Day 60 of placebo intervention

• Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

  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.

  Day 1 of treatment intervention, before treatment consumption

• Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

  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.

  Day 60 of treatment intervention

• Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

  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.

  Day 1 of placebo intervention, before placebo consumption

• Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)

  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.

  Day 60 of placebo intervention

Secondary Outcomes (139)

• C-Reactive Protein (CRP) Measure

  Immediately after enrollment, 30 days before start of intervention

• CRP Measure

  Day 1 of treatment intervention, before treatment consumption

• CRP Measure

  Day 30 of treatment intervention

• CRP Measure

  Day 60 of treatment intervention

• CRP Measure

  Day 1 of placebo intervention, before placebo consumption

Study Arms (2)

1-Blueberry First/Placebo First

OTHER

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

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

2-Crossover

OTHER

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

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

Interventions

Freeze Dried Blueberry Powder - 71717 DIETARY_SUPPLEMENT

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.

Also known as: Tifblue/Rubel 50/50 Blend

1-Blueberry First/Placebo First; 2-Crossover

USHBC Blueberry Placebo Formula #114 DIETARY_SUPPLEMENT

Blueberry flavor- and color-matched placebo powder.

1-Blueberry First/Placebo First; 2-Crossover

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University, Baton Rouge: lead
• U.S. Highbush Blueberry Council: collaborator
• Louisiana Health Care Practitioners, LLC: collaborator
• Collective Healthcare Solutions, LLC: collaborator
• uBiome, Inc.: collaborator

Study Sites (2)

Cottonport Family Clinic

Cottonport, Louisiana, 71327, United States

Location

Marksville Family Clinic

Marksville, Louisiana, 71351, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Francis, Ph.D.

  Louisiana State University, Baton Rouge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blueberry treatment and placebo powders have been supplied by the U.S. Highbush Blueberry Council; packets are labeled either alpha or omega. The treatment powder is a freeze-dried whole blueberry powder, and the placebo is a color- and flavor-matched powder which has been used in previous trials. Only an unblinded research assistant will have knowledge of which label corresponds to blueberry or placebo. That research assistant will be in charge of: (1) Before each appointment, distributing appropriate treatment or placebo packets into closable boxes with a number corresponding to each participant. Care-providers will give closed boxes to participants at the time of assessment. (2) Re-labeling all collected data and samples with a participant code number, and sorting into appropriate groups for analysis by blinded researchers.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will utilize a randomized, double-blind, placebo-controlled, crossover design. 60 participants with depression will be randomized into either the placebo first or blueberry first group. Randomization will be based on outcomes from behavioral measures (Major Depression Inventory and GAD-7) and a physiological measure (C-reactive protein levels) in appointment 0. The first arm will consist of 12 weeks of daily treatment and baseline (pre-intervention), mid-intervention and post-intervention assessments. Next there will be a four week washout period, after which patients will switch treatments, and the second arm will commence--identical to the first in structure. Further, the study is a repeated measures design with each participant's baseline measures serving as her or his own control.

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: May 21, 2020
• Study Start: April 15, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)