Probiotic Administration on Mood (PAM)

• ClinicalTrials.gov Identifier: NCT05343533
• Recruitment Status: Completed
• First Posted: April 25, 2022
• Last Update Posted: April 25, 2022
• Sponsor: Lindenwood University
• Collaborator: Increnovo, LLC
• Information provided by (Responsible Party): Lindenwood University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Depression; Sleep; Stress; Anxiety; Mood Disorders	Dietary Supplement: Probiotic	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: andomized, double-blind, placebo-controlled, parallel study design that will evaluate the ability of a probiotic to influence mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a group of healthy men and women
• Masking: Double (Participant, Investigator)
• Masking Description: All supplements were blinded from participant and investigator by a third party
• Primary Purpose: Other
• Official Title: Impact of Probiotic Administration on Mood, Psychological Traits, Physical Activity, Stress, and Sleep Quality
• Actual Study Start Date: July 17, 2019
• Actual Primary Completion Date: January 1, 2022
• Actual Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
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).	Dietary Supplement: 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 Comparator: Placebo; Maltodextrin capsule	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures :

1. Beck Depression Index II [ Time Frame: 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

2. COPE Inventory [ Time Frame: 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).
3. Leiden Index of Depression Sensitivity - Revised [ Time Frame: 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.
4. Pittsburgh Sleep Quality Index [ Time Frame: 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

5. State-Trait Anxiety Inventory form Y1 and Y2 [ Time Frame: 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. Behavioral Avoidance/Inhibition Scale [ Time Frame: 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.
7. Bowel Health Questionnaire [ Time Frame: 6 weeks ]
   Measure of bowel health. Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances

Secondary Outcome Measures :

1. Hours Asleep [ Time Frame: 6 weeks ]
   Total hours asleep each night as obtained through a fit bit activity monitor
2. Minutes Awake [ Time Frame: 6 weeks ]
   Total minutes awake each night as obtained through a fit bit activity monitor
3. Number of awakenings [ Time Frame: 6 weeks ]
   Number of times awakened each night as obtained through a FitBit activity monitor
4. Minutes of restlessness [ Time Frame: 6 weeks ]
   Total minutes of restlessness each night as obtained through a FitBit activity monitor
5. Number of times Restless [ Time Frame: 6 weeks ]
   Number of times restless each night as obtained through a FitBit activity monitor
6. Total time Awake and Restless [ Time Frame: 6 weeks ]
   Total minutes of time awake and restless each night as obtained through a FitBit activity monitor
7. Total time in Bed [ Time Frame: 6 weeks ]
   Total time in bed each night as obtained through a FitBit activity monitor
8. Calories Burned [ Time Frame: 6 weeks ]
   Total KCal burned on average each day as obtained through a FitBit activity monitor
9. Steps [ Time Frame: 6 weeks ]
   Total number of steps on average each day as obtained through a FitBit activity monitor
10. Distance [ Time Frame: 6 weeks ]
    Total distance traveled each day on average each day as obtained through a FitBit activity monitor
11. Minutes Sedentary [ Time Frame: 6 weeks ]
    Total minutes sedentary on average each day as obtained through a FitBit activity monitor
12. Minutes Lightly Active [ Time Frame: 6 weeks ]
    Total minutes Lightly active on average each day as obtained through a FitBit activity monitor
13. Minutes Fairly Active [ Time Frame: 6 weeks ]
    Total minutes Fairly active on average each day as obtained through a FitBit activity monitor
14. Minutes Very Active [ Time Frame: 6 weeks ]
    Total minutes Very active on average each day as obtained through a FitBit activity monitor
15. Active Calories [ Time Frame: 6 weeks ]
    Total minutes of active calories expended on average each day as obtained through a FitBit activity monitor
16. Body Composition [ Time Frame: 6 weeks ]
    DEXA derived fat mass and fat free mass and bodyfat percentage

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Missouri

Lindenwood University

Saint Charles, Missouri, United States, 63301

Sponsors and Collaborators

Lindenwood University

Increnovo, LLC

More Information

• Responsible Party: Lindenwood University
• ClinicalTrials.gov Identifier: NCT05343533
• Other Study ID Numbers: IRB-19-212
• First Posted: April 25, 2022
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mood Disorders; Mental Disorders