Probiotics Effect on Mental Wellness

NCT ID: NCT05709067

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-09-16

Brief Summary

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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

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Conditions

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Mental Health Wellness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic Arm

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

6 Billion CFU per day

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

0 CFU per day

Interventions

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Probiotic

6 Billion CFU per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

0 CFU per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Genomics

UNKNOWN

Sponsor Role collaborator

Fonterra Research Centre

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Divya Nair

Role: PRINCIPAL_INVESTIGATOR

SunGenomics

Locations

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Sun Genomics, Inc.

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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Moa

Identifier Type: -

Identifier Source: org_study_id

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