Probiotic Administration on Mood

NCT05343533 | Completed

• 1 other identifier: IRB-19-212
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Sleep; Stress; Anxiety; Mood Disorders

Outcome Measures

Primary Outcomes (7)

• Beck Depression Index II

  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

  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

  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

  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

  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

  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

  Measure of bowel health. Lower scores indicate lower number of GI disturbances and higher scores indicate higher number of GI disturbances

  6 weeks

Secondary Outcomes (16)

• Hours Asleep

  6 weeks

• Minutes Awake

  6 weeks

• Number of awakenings

  6 weeks

• Minutes of restlessness

  6 weeks

• Number of times Restless

  6 weeks

Study Arms (2)

Active Probiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Maltodextrin capsule

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Active Probiotic; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenwood University: lead
• Increnovo, LLC: collaborator

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

Related Publications (2)

• Kerksick CM, Moon JM, Walden KE, Hagele AM, Allen LE, Gaige CJ, Krieger JM, Jager R, Pane M, Mumford P. Multi-strain probiotic improves subjective sleep quality with no impact on body composition, hemodynamics, and physical activity. Benef Microbes. 2024 Jan 31;15(2):179-194. doi: 10.1163/18762891-bja00002.

  PMID: 38350465 DERIVED

• Walden KE, Moon JM, Hagele AM, Allen LE, Gaige CJ, Krieger JM, Jager R, Mumford PW, Pane M, Kerksick CM. A randomized controlled trial to examine the impact of a multi-strain probiotic on self-reported indicators of depression, anxiety, mood, and associated biomarkers. Front Nutr. 2023 Aug 31;10:1219313. doi: 10.3389/fnut.2023.1219313. eCollection 2023.

  PMID: 37720373 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Mood Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All supplements were blinded from participant and investigator by a third party
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 25, 2022
• Study Start: July 17, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)