Prebiotics and Stress Reduction in Women

FrieslandCampina

Status: Completed

Conditions: Stress, Psychological

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Relax+

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372601

Stress Defense

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups, including a placebo group

Relax+

Experimental group

Description:

Relax+ consists of a powder containing a blend of two prebiotics.

Treatment:

Dietary Supplement: Relax+

Placebo

Placebo Comparator group

Description:

The placebo contains maltodextrin.

Treatment:

Dietary Supplement: Maltodextrin