Probiotics Effect on Mental Wellness

NCT05709067 | Completed

• 1 other identifier: Moa
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Stress scores

  4 weeks

• Change in anxiety scores

  4 weeks

• Change in Depression scores

  4 weeks

• Change in Salivary cortisol

  4 weeks

Study Arms (2)

Probiotic Arm

EXPERIMENTAL

Dietary Supplement: Probiotic

Control

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

6 Billion CFU per day

Probiotic Arm

Placebo DIETARY_SUPPLEMENT

0 CFU per day

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fonterra Research Centre: lead
• Sun Genomics: collaborator

Study Sites (1)

Sun Genomics, Inc.

San Diego, California, 92122, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Study Officials

• Divya Nair

  SunGenomics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: February 1, 2023
• Study Start: March 20, 2023
• Primary Completion: September 16, 2023
• Study Completion: September 16, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)