Prebiotics and Stress Reduction in Women

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372601
• Other study ID #: Stress Defense
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: June 18, 2022

Study information

• Verified date: March 2024
• Source: FrieslandCampina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 18, 2022
• Est. primary completion date: June 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Dietary Supplement:
• Relax+
Prebiotics, daily administered
• Maltodextrin
Placebo, daily administered

Locations

Country	Name	City	State
Netherlands	FrieslandCampina Research and Development	Wageningen

Sponsors (1)

Lead Sponsor	Collaborator
FrieslandCampina

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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