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Prebiotics and Stress Reduction in Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05372601
Enrollment
124
Registered
2022-05-13
Start date
2022-02-17
Completion date
2022-06-18
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Psychological

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTRelax+

Prebiotics, daily administered

DIETARY_SUPPLEMENTMaltodextrin

Placebo, daily administered

Sponsors

FrieslandCampina
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Perceived stress28 daysThe 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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026