Prebiotics and Stress Reduction in Women

NCT05372601 | Completed

• 1 other identifier: Stress Defense
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Relax+

EXPERIMENTAL

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

Dietary Supplement: Relax+

Placebo

PLACEBO COMPARATOR

The placebo contains maltodextrin.

Dietary Supplement: Maltodextrin

Interventions

Relax+ DIETARY_SUPPLEMENT

Prebiotics, daily administered

Relax+

Maltodextrin DIETARY_SUPPLEMENT

Placebo, daily administered

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FrieslandCampina: lead

Study Sites (1)

FrieslandCampina Research and Development

Wageningen, 6708 WH, Netherlands

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Reina S Tjoelker, MSc

  FrieslandCampina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: May 13, 2022
• Study Start: February 17, 2022
• Primary Completion: June 18, 2022
• Study Completion: June 18, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)