Prebiotics and Stress Reduction in Women

Study Overview
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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.

Official Title
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The Effect of Galacto-oligosaccharides (GOS) on Self-perceived Stress in Apparently Healthy But Stressed Dutch Women: Randomized Controlled Study

Conditions
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Stress, Psychological

Intervention / Treatment
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* Dietary Supplement: Relax+
* Dietary Supplement: Maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relax+<br>Relax+ consists of a powder containing a blend of two prebiotics. | Dietary Supplement: Relax+<br>* Prebiotics, daily administered<br>|
| Placebo Comparator: Placebo<br>The placebo contains maltodextrin. | Dietary Supplement: Maltodextrin<br>* Placebo, daily administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress | The difference in absolute stress sub-score after the product intervention between the product groups (using the Depression Anxiety Stress Scale (DASS-42)), in which a lower score corresponds with a lower stress level | 28 days |