Prebiotics and Stress Reduction in Women

Not Applicable

Completed

• Conditions: Stress, Psychological
• Interventions: Dietary Supplement: Relax+; Dietary Supplement: Maltodextrin

• Registration Number: NCT05372601
• Lead Sponsor: FrieslandCampina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study Start: 2022-02-17
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-13
• Primary Completion: 2022-06-18
• Study Completion: 2022-06-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relax+	Relax+	Relax+ consists of a powder containing a blend of two prebiotics.
Placebo	Maltodextrin	The placebo contains maltodextrin.

Primary Outcome Measures

Name	Time	Method
Perceived stress	28 days	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

Trial Locations

Locations (1)

FrieslandCampina Research and Development; 🇳🇱 Wageningen, Netherlands