Probiotics Effect on Mental Wellness

Not Applicable

Completed

• Conditions: Mental Health Wellness
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT05709067
• Lead Sponsor: Fonterra Research Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-29
• Study First Posted: 2023-02-01
• Study Start: 2023-03-20
• Primary Completion: 2023-09-16
• Study Completion: 2023-09-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic Arm	Probiotic	-
Control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Mental wellbeing	4 weeks	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".

Secondary Outcome Measures

Name	Time	Method
Change in Stress scores	4 weeks	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.
Change in Depression scores	4 weeks	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 .
Change in Salivary cortisol	4 weeks	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.
Change in anxiety scores	4 weeks	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.

Trial Locations

Locations (1)

Sun Genomics, Inc.; 🇺🇸 San Diego, California, United States