Probiotic Administration on Mood (PAM)
Impact of Probiotic Administration on Mood, Psychological Traits, Physical Activity, Stress, and Sleep Quality
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Missouri
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Saint Charles、Missouri、アメリカ、63301
- Lindenwood University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- between the ages of 18 - 50 years
- has a body mass index between 18.5 - 30 kg/m2.
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Active Probiotic
A mixture of probiotic strains (2.5 gram daily doses of 4 x 109 CFU/packet) of the following species (Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium longum).
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After baseline or initial testing, participants will be randomly assigned in a double-blind fashion to ingest on a daily basis for 6 weeks either a placebo or a probiotic supplement.
Identical follow-up measurements will then occur each visit after taking their assigned supplement.
After 6 weeks of administration, the supplementation protocol will stop and a final evaluation will be completed 3 weeks later (9 weeks after initial administration) to assess any residual impact of the assigned supplement after a 3-week washout.
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プラセボコンパレーター：Placebo
Maltodextrin capsule
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After baseline or initial testing, participants will be randomly assigned in a double-blind fashion to ingest on a daily basis for 6 weeks either a placebo or a probiotic supplement.
Identical follow-up measurements will then occur each visit after taking their assigned supplement.
After 6 weeks of administration, the supplementation protocol will stop and a final evaluation will be completed 3 weeks later (9 weeks after initial administration) to assess any residual impact of the assigned supplement after a 3-week washout.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Beck Depression Index II
時間枠：6 Weeks
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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 |
6 Weeks
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COPE Inventory
時間枠：6 weeks
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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).
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6 weeks
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Leiden Index of Depression Sensitivity - Revised
時間枠：6 weeks
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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.
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6 weeks
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Pittsburgh Sleep Quality Index
時間枠：6 weeks
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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 |
6 weeks
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State-Trait Anxiety Inventory form Y1 and Y2
時間枠：6 weeks
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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.
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6 weeks
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Behavioral Avoidance/Inhibition Scale
時間枠：6 weeks
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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.
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6 weeks
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Bowel Health Questionnaire
時間枠：6 weeks
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Measure of bowel health.
Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances
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6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Hours Asleep
時間枠：6 weeks
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Total hours asleep each night as obtained through a fit bit activity monitor
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6 weeks
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Minutes Awake
時間枠：6 weeks
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Total minutes awake each night as obtained through a fit bit activity monitor
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6 weeks
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Number of awakenings
時間枠：6 weeks
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Number of times awakened each night as obtained through a FitBit activity monitor
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6 weeks
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Minutes of restlessness
時間枠：6 weeks
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Total minutes of restlessness each night as obtained through a FitBit activity monitor
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6 weeks
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Number of times Restless
時間枠：6 weeks
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Number of times restless each night as obtained through a FitBit activity monitor
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6 weeks
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Total time Awake and Restless
時間枠：6 weeks
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Total minutes of time awake and restless each night as obtained through a FitBit activity monitor
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6 weeks
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Total time in Bed
時間枠：6 weeks
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Total time in bed each night as obtained through a FitBit activity monitor
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6 weeks
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Calories Burned
時間枠：6 weeks
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Total KCal burned on average each day as obtained through a FitBit activity monitor
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6 weeks
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Steps
時間枠：6 weeks
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Total number of steps on average each day as obtained through a FitBit activity monitor
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6 weeks
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Distance
時間枠：6 weeks
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Total distance traveled each day on average each day as obtained through a FitBit activity monitor
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6 weeks
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Minutes Sedentary
時間枠：6 weeks
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Total minutes sedentary on average each day as obtained through a FitBit activity monitor
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6 weeks
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Minutes Lightly Active
時間枠：6 weeks
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Total minutes Lightly active on average each day as obtained through a FitBit activity monitor
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6 weeks
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Minutes Fairly Active
時間枠：6 weeks
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Total minutes Fairly active on average each day as obtained through a FitBit activity monitor
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6 weeks
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Minutes Very Active
時間枠：6 weeks
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Total minutes Very active on average each day as obtained through a FitBit activity monitor
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6 weeks
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Active Calories
時間枠：6 weeks
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Total minutes of active calories expended on average each day as obtained through a FitBit activity monitor
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6 weeks
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Body Composition
時間枠：6 weeks
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DEXA derived fat mass and fat free mass and bodyfat percentage
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6 weeks
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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Probioticの臨床試験
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Vancouver Island Health AuthorityCanadian Society of Hospital Pharmacists; Jamieson Laboratories Ltd, Canada終了しました