The effect of Galacto-oligosaccharides (GOS) on self-perceived stress in apparently healthy but stressed Dutch women: randomized controlled study

Completed

Conditions: Stress
self-perceived stress
stress

Registration Number: NL-OMON51276

Lead Sponsor: FrieslandCampina

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

* Apparently healthy women (based on lifestyle questionnaire)
* 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, and willing to install an app

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
* Being an employee of FrieslandCampina

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effect of 28-days consumption of GOSplus on the DASS42 derived<br /><br>stress sub-score in a population of healthy Dutch women (25-45 years), who<br /><br>perceive stress on a regular basis, compared to a placebo (maltodextrin).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effect of 14 days consumption of GOSplus on the DASS42 derived<br /><br>stress sub-score, compared to a placebo (maltodextrin).<br /><br>To assess the effect of 28- and 14-days consumption of GOSplus on the DASS42<br /><br>derived anxiety sub-score, compared to a placebo (maltodextrin).<br /><br>To assess the effect of 28 days consumption of GOSplus on early morning<br /><br>cortisol levels in saliva, compared to placebo (maltodextrin).<br /><br>To assess the effect of 28- and 14-days consumption of GOSplus, or<br /><br>maltodextrin, on the changes (baseline versus endline) in DASS42 derived stress<br /><br>and anxiety sub-score, and early morning cortisol levels in saliva.</p><br>