Impact of Probiotic Administration on Mood, Psychological Traits, Physical Activity, Stress, and Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Beck Depression Index II
研究概览
简要总结
Researchers are looking to examine the impact of probiotic administration on symptoms commonly associated with depression, anxiety, stress, sleep quality, and associated emotional responses in healthy men and women.
详细描述
In recent years, the presence and awareness of a connection between the intestines and the brain has expanded leading to the understanding of developed communication pathways between the nervous, endocrine, and immune systems. Intestinal bacterial flora are active contributors to this axis through cellular signaling pathways and the release of immune system components, which fundamentally impact the function and action of various physiological systems. Interest in this area evolved through the understanding that various microbiota can produce neuroactive substances and neurotransmitters involved with the endocrine and autonomic nervous system pathways. This research has expanded to state that various bacterial products can influence cognitive functions, involving types of memory and problem-solving. Recent findings have begun to report on the impact that probiotic administration may have on mood, anxiety, and depression. Finally, recent work by Marotta et al. provided some of the first preliminary evidence that probiotic use may also impact mood and sleep quality. While initial work has developed this foundation, very little controlled research is available to help understand key contributing factors. For example, many key questions remain that future research should address to help better understand any impact probiotics may have on mood, depression, and anxiety. Some of these questions include:
Do all forms (genus, strain, etc.) of probiotics exert these impacts? How quickly do they exert impact? How large is the impact? Are certain aspect of affect more impacted than others? Once supplemented, how long is the residual impact (if there is any)? To help provided more guidance towards some of these basic research questions, this study is being proposed. The purpose of the study is to expand upon the previous work of Marotta et al. and determine the impact of probiotic administration on mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a larger group of healthy men and women. This study will expand on the supplementation regimen and include a wider variety of hormonal assessments than what has previously been completed using this combination of probiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
All supplements were blinded from participant and investigator by a third party
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between the ages of 18 - 50 years
- •has a body mass index between 18.5 - 30 kg/m
- •Anyone with a body mass index between 30 - 32 kg/m2, but has a body composition <25% fat -for men and <35% for women will be accepted into the study
- •has been weight stable for the past three months (defined as less than a 5% variation in body -mass over this time)
- •is determined to be healthy through completion of a health history questionnaire
排除标准
- •Are currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, - renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
- •are currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
- •report having used anabolic steroids within the past 30 days
- •report have used any illicit or recreational drugs within the past 30 days
- •report the intake of any prescription or over-the-counter medications (i.e., antibiotics) that may impact study outcomes
- •report the current use of any dietary supplements known to impact digestion or sleep quality for the past 30 days
- •report already taking a probiotic within the past 30 days
- •have been actively trying to lose weight
- •are currently following a ketogenic or low carbohydrate diet within the past 30 days
结局指标
主要结局
Beck Depression Index II
时间窗: 6 Weeks
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Total Score Levels of Depression 0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression
COPE Inventory
时间窗: 6 weeks
The COPE Inventory is a multidimensional coping inventory to assess the different ways in which people respond to stress. Five scales (of four items each) measure conceptually distinct aspects of problem-focused coping (active coping, planning, suppression of competing activities, restraint coping, seeking of instrumental social support); five scales measure aspects of what might be viewed as emotion-focused coping (seeking of emotional social support, positive reinterpretation, acceptance, denial, turning to religion); and three scales measuring coping responses that arguably are less useful (focus on and venting of emotions, behavioral disengagement, mental disengagement).
State-Trait Anxiety Inventory form Y1 and Y2
时间窗: 6 weeks
Measure of trait and state anxiety. All items on the scale are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level.
Behavioral Avoidance/Inhibition Scale
时间窗: 6 weeks
A measure of motivation to approach goal-oriented outcomes. Higher scores correspond to higher motivation to avoid goal oriented outcomes, lower scores indicate lower motivation to avoid goal-oriented outcomes.
Bowel Health Questionnaire
时间窗: 6 weeks
Measure of bowel health. Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances
Leiden Index of Depression Sensitivity - Revised
时间窗: 6 weeks
The Leiden Index of Depression Sensitivity (LEIDS) measures cognitive reactivity (CR) to sadness, an aspect of cognitive vulnerability to depression, conceptually similar to rumination. A higher total score on all the subscales except acceptance and coping shows higher CR.
Pittsburgh Sleep Quality Index
时间窗: 6 weeks
A self-rated questionnaire to assess sleep quality and disturbances 19 self-reported items Minimum score: 0; Maximum score: 21 Higher scoring indicated worse sleep quality
次要结局
- Hours Asleep(6 weeks)
- Total time in Bed(6 weeks)
- Minutes Very Active(6 weeks)
- Calories Burned(6 weeks)
- Steps(6 weeks)
- Active Calories(6 weeks)
- Minutes Awake(6 weeks)
- Number of awakenings(6 weeks)
- Total time Awake and Restless(6 weeks)
- Minutes Sedentary(6 weeks)
- Minutes Lightly Active(6 weeks)
- Minutes Fairly Active(6 weeks)
- Number of times Restless(6 weeks)
- Minutes of restlessness(6 weeks)
- Distance(6 weeks)
- Body Composition(6 weeks)