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OpenTrials
Completed

NCT Number: NCT05372601

Prebiotics and Stress Reduction in Women

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

FrieslandCampina Research and Development

Wageningen, 6708 WH, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relax+

Dietary Supplement

Prebiotics, daily administered

Maltodextrin

Dietary Supplement

Placebo, daily administered

Primary outcomes

  1. Perceived stress

    Time frame: 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

Sponsors and collaborators

Lead sponsor

FrieslandCampina

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 13, 2022
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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