Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Major Depression Inventory (MDI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
- •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
结局指标
主要结局
Major Depression Inventory (MDI)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Concentration of tryptophan(Day 60 of placebo intervention)
- Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4)(Day 1 of treatment intervention, before treatment consumption)
- CRP Measure(Day 60 of placebo intervention)
- Concentration of reactive oxygen species (ROS)(Day 60 of placebo intervention)
- Concentration of kynurenine(Day 60 of placebo intervention)
- Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1)(Day 1 of treatment intervention, before treatment consumption)
- Gut Microbiome Analysis(Day 60 of placebo intervention)
- Concentration of quinolinic acid(Day 60 of placebo intervention)
- Concentration of indoleamine 2,3-dioxygenase (IDO)(Day 60 of placebo intervention)
- Concentration of glial cell line-derived neurotropic factor (GDNF)(Day 60 of placebo intervention)
- Concentration of serotonin related compound SERT(Day 60 of placebo intervention)
- Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA)(Day 1 of treatment intervention, before treatment consumption)
- Concentration of cortisol(Day 60 of placebo intervention)
- C-Reactive Protein (CRP) Measure(Immediately after enrollment, 30 days before start of intervention)
- Leeds Sleep Evaluation Questionnaire (LSEQ)(Day 60 of placebo intervention)
- Concentration of kynurenic acid(Day 60 of placebo intervention)
- Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2)(Day 1 of treatment intervention, before treatment consumption)
- Concentration of suicide-associated protein SKA-2(Day 60 of placebo intervention)
- Concentration of glutamate(Day 60 of placebo intervention)
- Concentration of suicide-associated protein SLC4A4(Day 60 of placebo intervention)
- Concentration of serotonin related compound serotonin transporter (SERT)(Day 1 of treatment intervention, before treatment consumption)
- Concentration of serotonin related compound 5-HIAA(Day 60 of placebo intervention)
- Concentration of glutamine(Day 60 of placebo intervention)
- Concentration of inflammation biomarker interferon gamma (IFN-gamma)(Day 60 of placebo intervention)
- Concentration of suicide-associated protein SAT-1(Day 60 of placebo intervention)
- Concentration of brain-derived neurotropic factor (BDNF)(Day 60 of placebo intervention)
- Concentration of inflammation biomarker interleukin 6 (IL-6)(Day 60 of placebo intervention)
- Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)(Day 60 of placebo intervention)
- Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)(Day 60 of placebo intervention)
研究者
Joseph Francis, Ph.D
Professor
Louisiana State University, Baton Rouge