Prebiotics and Stress Reduction in Women

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

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2022-06-18

Brief Summary

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In modern life, many people state to experience stress. Women compared to men report more and higher levels of stress. Recent research found that supplementation of galactose-oligosaccharides (GOS) resulted in reduced anxiety levels in British female students with higher anxiety scores at baseline in self-reported trait anxiety. Moreover, supplementation of probiotics in germ-free rodents resulted in reduced levels of circulating corticosterone (cortisol in humans). These findings illustrate the potential of prebiotic supplementation, through the microbiota-gut-brain (MGB) axis, to improve mental health and wellbeing.

The present study aims to study the effect of oligosaccharides on self-perceived stress.

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Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Relax+

Relax+ consists of a powder containing a blend of two prebiotics.

Group Type EXPERIMENTAL

Relax+

Intervention Type DIETARY_SUPPLEMENT

Prebiotics, daily administered

Placebo

The placebo contains maltodextrin.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Placebo, daily administered

Interventions

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Relax+

Prebiotics, daily administered

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Placebo, daily administered

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy women
* Moderate or high stress level; DASS42 stress sub-score ≥19
* Age between 25 and 45 years
* Body mass index (BMI) between 18.5 and 30 kg/m2
* Access to internet and a smart phone

Exclusion Criteria

* Any metabolic, gastrointestinal, inflammatory or chronic disease
* History of gastro-intestinal surgery or having (serious) gastrointestinal discomfort
* Use of supplement to relief stress during or within 2 weeks prior to the start of the study
* Use of pre- and/or probiotics during the study (except for the study product) or within 4 weeks prior to the start of the study
* Use of medication that may influence the study results, such as laxatives
* Self-reported and/or clinical lactose intolerance
* Self-reported and/or active cow's milk protein allergy
* Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported)
* Having used antibiotics in the 6 months prior to the start of the study

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes