Probiotics Effect on Mental Wellness (Moa)

The goal of this clinical trial is to compare the effect of a probiotic strain on mental wellbeing in moderately stressed, healthy, adults in the general population. The main question it aims to answer is

• what is the impact of probiotic consumption on overall mental wellbeing? Participants will consume one probiotic or placebo capsule per day, answer a set of questionnaire (at 3 time points) and wear a wearable device for the total duration of the study.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • Sun Genomics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged between 18-60 years old
• Currently living in the US.
• Have access to a smart phone, internet and computer.
• Report moderate levels of perceived stress.

Exclusion Criteria:

• Are currently taking medication for depression or anxiety
• Have had antibiotics within the previous month
• Have an allergy to coconut

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Dietary supplement: Placebo; 0 CFU per day
Experimental: Probiotic Arm	Dietary supplement: Probiotic; 6 Billion CFU per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mental wellbeing	Improvement in mental wellbeing will be measured using the Oxford Happiness Questionnaire (OHQ). The Oxford Happiness Inventory was devised as a broad measure of personal happiness. The OHQ has a total of 29 items. Each item is scored on a Likert scale from 1 to 6 (1=strongly disagree; 2=moderately disagree; 3=slightly disagree; 4=slightly agree; 5=moderately agree; 6=strongly agree). Some items are phrased positively and others negatively. Such that negative items (1, 3, 12, 13, 16, 18, 21 and 29) should be scored in reverse (Hills & Argyle, 2002). The total score is then divided by 29. Interpretation of the final score is as follows: A final score between 1 to 2 is considered "not happy"; between 2 and 3 is "somewhat unhappy"; between 3 and 4 is considered "Neutral"; 4 is "somewhat or moderately happy"; between 4 and 5 is "rather happy"; between 5 and 6 is "very happy"; 6 is "too happy".	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress scores	Change in stress scores will be measured using the short version of the Depression, Anxiety, Stress Scale (DASS-21). Each item is scored from 0 to 3, with a score of 0 indicating that the statement did not apply or never. A score of 3 indicates that the statement applied very much or almost always. In DASS-21, items 1, 6, 8, 11, 12, 14 and 18 relate to measurement of stress. Given that DASS-21 is the short version of DASS-42, the total item score is multiplied by 2. The final total scores range from 0 (no stress) to 42 (extremely stressed). Scores ranging between 0-14 (stress) are considered normal. Scores above 14 are considered positive for stress.	4 weeks
Change in anxiety scores	Change in anxiety scores will be measured using the short version of the Depression, Anxiety, Stress Scale (DASS-21). Each item is scored from 0 to 3, with a score of 0 indicating that the statement did not apply or never. A score of 3 indicates that the statement applied very much or almost always. In DASS-21, items 2, 4, 7, 9, 15, 19 and 20 relate to measurement of anxiety. Given that DASS-21 is the short version of DASS-42, the total item score is multiplied by 2. The final total scores range from 0 (no anxiety) to 42 (extremely anxious). Scores ranging between 0-14 (stress) are considered normal. Scores above 14 are considered positive for anxiety.	4 weeks
Change in Depression scores	Change in depression scores will be measured using the short version of the Depression, Anxiety, Stress Scale (DASS-21). Each item is scored from 0 to 3, with a score of 0 indicating that the statement did not apply or never. A score of 3 indicates that the statement applied very much or almost always. In DASS-21, items 3, 5, 10, 13, 16, 17, and 21 relate to measurement of depression . Given that DASS-21 is the short version of DASS-42, the total item score is multiplied by 2. The final total scores range from 0 (no depression ) to 42 (extremely depressed). Scores ranging between 0-14 (stress) are considered normal. Scores above 14 are considered positive for depression .	4 weeks
Change in Salivary cortisol	The saliva kit contains contains a 15 ml sterile plastic tube with lid and instructions. The instructions outline that the participant will need to self-collect the saliva sample before going to bed by spitting into the tube to fill up ½ of the tube. The collection process should take no more than 15-30 minutes total. The participant shall writ their name, the date, and the time of collection on the tube. The full sample volume will be used for measurement.	4 weeks

Collaborators and Investigators

• Sponsor: Fonterra Research Centre
• Collaborators: Sun Genomics
• Investigators: Principal Investigator: Divya Nair, SunGenomics

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): September 16, 2023
• Study Completion (Actual): September 16, 2023

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Moa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No