Back to resultsPrebiotics and Stress Reduction in Women
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Relax+
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological
Eligibility Criteria
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
Sites / Locations
- FrieslandCampina Research and Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Relax+
Placebo
Arm Description
Relax+ consists of a powder containing a blend of two prebiotics.
The placebo contains maltodextrin.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05372601
Brief Title
Prebiotics and Stress Reduction in Women
Official Title
The Effect of Galacto-oligosaccharides (GOS) on Self-perceived Stress in Apparently Healthy But Stressed Dutch Women: Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
June 18, 2022 (Actual)
Study Completion Date
June 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FrieslandCampina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relax+
Arm Type
Experimental
Arm Description
Relax+ consists of a powder containing a blend of two prebiotics.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo contains maltodextrin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Relax+
Intervention Description
Prebiotics, daily administered
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Placebo, daily administered
Primary Outcome Measure Information:
Title
Perceived stress
Description
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
Time Frame
28 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reina S Tjoelker, MSc
Organizational Affiliation
FrieslandCampina
Official's Role
Principal Investigator
Facility Information:
Facility Name
FrieslandCampina Research and Development
City
Wageningen
ZIP/Postal Code
6708 WH
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Prebiotics and Stress Reduction in Women
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