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Probiotic Administration on Mood (PAM)

20. April 2022 aktualisiert von: Lindenwood University

Impact of Probiotic Administration on Mood, Psychological Traits, Physical Activity, Stress, and Sleep Quality

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Missouri
      • Saint Charles, Missouri, Vereinigte Staaten, 63301
        • Lindenwood University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Nahrungsergänzungsmittel: Probiotic
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.
Placebo-Komparator: Placebo
Maltodextrin capsule
Nahrungsergänzungsmittel: Probiotic
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Beck Depression Index II
Zeitfenster: 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
6 Weeks
COPE Inventory
Zeitfenster: 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).
6 weeks
Leiden Index of Depression Sensitivity - Revised
Zeitfenster: 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.
6 weeks
Pittsburgh Sleep Quality Index
Zeitfenster: 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
6 weeks
State-Trait Anxiety Inventory form Y1 and Y2
Zeitfenster: 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.
6 weeks
Behavioral Avoidance/Inhibition Scale
Zeitfenster: 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.
6 weeks
Bowel Health Questionnaire
Zeitfenster: 6 weeks
Measure of bowel health. Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances
6 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hours Asleep
Zeitfenster: 6 weeks
Total hours asleep each night as obtained through a fit bit activity monitor
6 weeks
Minutes Awake
Zeitfenster: 6 weeks
Total minutes awake each night as obtained through a fit bit activity monitor
6 weeks
Number of awakenings
Zeitfenster: 6 weeks
Number of times awakened each night as obtained through a FitBit activity monitor
6 weeks
Minutes of restlessness
Zeitfenster: 6 weeks
Total minutes of restlessness each night as obtained through a FitBit activity monitor
6 weeks
Number of times Restless
Zeitfenster: 6 weeks
Number of times restless each night as obtained through a FitBit activity monitor
6 weeks
Total time Awake and Restless
Zeitfenster: 6 weeks
Total minutes of time awake and restless each night as obtained through a FitBit activity monitor
6 weeks
Total time in Bed
Zeitfenster: 6 weeks
Total time in bed each night as obtained through a FitBit activity monitor
6 weeks
Calories Burned
Zeitfenster: 6 weeks
Total KCal burned on average each day as obtained through a FitBit activity monitor
6 weeks
Steps
Zeitfenster: 6 weeks
Total number of steps on average each day as obtained through a FitBit activity monitor
6 weeks
Distance
Zeitfenster: 6 weeks
Total distance traveled each day on average each day as obtained through a FitBit activity monitor
6 weeks
Minutes Sedentary
Zeitfenster: 6 weeks
Total minutes sedentary on average each day as obtained through a FitBit activity monitor
6 weeks
Minutes Lightly Active
Zeitfenster: 6 weeks
Total minutes Lightly active on average each day as obtained through a FitBit activity monitor
6 weeks
Minutes Fairly Active
Zeitfenster: 6 weeks
Total minutes Fairly active on average each day as obtained through a FitBit activity monitor
6 weeks
Minutes Very Active
Zeitfenster: 6 weeks
Total minutes Very active on average each day as obtained through a FitBit activity monitor
6 weeks
Active Calories
Zeitfenster: 6 weeks
Total minutes of active calories expended on average each day as obtained through a FitBit activity monitor
6 weeks
Body Composition
Zeitfenster: 6 weeks
DEXA derived fat mass and fat free mass and bodyfat percentage
6 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Lindenwood University

Mitarbeiter

Increnovo, LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Juli 2019

Primärer Abschluss (Tatsächlich)

1. Januar 2022

Studienabschluss (Tatsächlich)

1. Januar 2022

Studienanmeldedaten

Zuerst eingereicht

29. März 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. April 2022

Zuerst gepostet (Tatsächlich)

25. April 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-19-212

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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