Probiotics Effect on Mental Wellness

Mental Health Wellness Clinical Trial

— Moa  

Official title:

Probiotics Effect on Mental Wellness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05709067
• Other study ID #: Moa
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: September 16, 2023

Study information

• Verified date: February 2024
• Source: Fonterra Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 16, 2023
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness

Intervention

Dietary Supplement:
• Probiotic
6 Billion CFU per day
• Placebo
0 CFU per day

Locations

Country	Name	City	State
United States	Sun Genomics, Inc.	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Fonterra Research Centre	Sun Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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