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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological
• Intervention / Treatment: Dietary supplement: Relax+; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Wageningen, Netherlands, 6708 WH
    • FrieslandCampina Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relax+; Relax+ consists of a powder containing a blend of two prebiotics.	Dietary supplement: Relax+; Prebiotics, daily administered
Placebo Comparator: Placebo; The placebo contains maltodextrin.	Dietary supplement: Maltodextrin; Placebo, daily administered

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Investigators: Principal Investigator: Reina S Tjoelker, MSc, FrieslandCampina

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): June 18, 2022
• Study Completion (Actual): June 18, 2022

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: Stress Defense

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No