Probiotics, Immunity, Stress, and QofL

Not Applicable

Completed

• Conditions: Stress; Quality of Life
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT05063305
• Lead Sponsor: Loma Linda University

Brief Summary

The purpose of this graduate student research study is to evaluate the efficacy of a multi-strain probiotic and investigate if sex differences influence the role of probiotics on stress and immunity biomarkers.

Detailed Description

Visit #1

* Participants will read and sign informed consent forms, HIPPA form, and SAHP Covid-19 screening form.

* Participants will perform a baseline oral saliva swab to test for the stress biomarker cortisol and immune markers, including Interleukin-1β (IL-1β) and Tumor Necrosis Factor (TNF).

* Swabs will be individually packaged. After opening the package, participants will place the swab under their tongue for 1-2 minutes.

* After swabbing is complete, the swab will be placed into the collection tube and capped immediately.

* Completed swabs will be placed and held in a sub negative 70° Fahrenheit freezer.

* Participants will complete a Quality-of-Life Questionnaire (10-15 minutes).

* As this study is double blinded, participants will be separated by gender (male and female) and will select a 90-day supply of placebo or probiotic sample at random. For each gender group there will be 50 samples to select from, comprised of a mix of 25 placebo and 25 probiotic bottles.

* Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the probiotic at a similar time each day (example: always take it in the morning or evening) Visit #2

* Participants will complete the same Quality-of-Life Questionnaire from visit #1

* Participants will perform a post-study oral saliva swab in the same manner as visit #1

Study Timeline

• Study First Submitted: 2021-09-13
• Study Start: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-01
• Primary Completion: 2022-01-27
• Study Completion: 2022-01-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Males and Females
• 18-90 years of age
• Participants should be of good health

Exclusion Criteria

• Women who are self-reported as pregnant and/or breastfeeding
• Those who suffer from any systemic illness, such as diabetes mellitus, HIV, cancer, or chronic kidney disease.
• Persons who are diagnosed with clinical depression or anxiety, or other mental health diagnoses such as schizophrenia or Alzheimer's.
• Persons who have taken any probiotic for 5 or more days in the 3 months prior to the trial
• Persons having received antibiotics or non-steroid anti-inflammatory therapy in the last 3-month period prior to the study
• Persons who work night shift
• Persons who consume probiotic rich foods daily, such as yogurt, kimchi, kombucha, kefir, sauerkraut, tempeh, miso, and buttermilk
• Anyone who is allergic to any ingredient in the probiotic or placebo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Male Placebo	Placebo	• Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening)
Male Probiotic	Probiotic	• Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening)
Female Probiotic	Probiotic	• Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening)
Female Placebo	Placebo	• Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening)

Primary Outcome Measures

Name	Time	Method
Saliva Sample Cortisol	Change in cortisol uL between baseline and 90 days	Baseline and post-study oral saliva samples will be tested for the stress biomarker cortisol uL.

Secondary Outcome Measures

Name	Time	Method
Saliva Sample IL-1	Change in Interleukin-1β (IL-1β) uL between baseline and 90 days	Baseline and post-study oral saliva samples will be tested for Interleukin-1β (IL-1β) uL.
Saliva Sample Tumor Necrosis Factor	Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days	Baseline and post-study oral saliva samples will be tested for Tumor Necrosis Factor (TNF) uL.

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States