Stress, PsychologicalNCT05372601
Prebiotics and Stress Reduction in Women
A study testing Relax+ and Maltodextrin in people with Stress, Psychological, run by FrieslandCampina at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Relax+ and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2022to 18 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
FrieslandCampina Research and Development
Wageningen, 6708 WH
About this study
Official title: The Effect of Galacto-oligosaccharides (GOS) on Self-perceived Stress in Apparently Healthy But Stressed Dutch Women: Randomized Controlled Study
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
- Being tested
- Relax+, Maltodextrin
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relax+Dietary supplement
Prebiotics, daily administered
MaltodextrinDietary supplement
Placebo, daily administered
| Study group | Role | What they receive |
|---|---|---|
| Relax+ | Experimental | Relax+ consists of a powder containing a blend of two prebiotics. Receives: Dietary Supplement: Relax+ |
| Placebo | Placebo comparator | The placebo contains maltodextrin. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start17 Feb 2022
- Primary completion18 Jun 2022
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reina S Tjoelker, MSc, Principal investigator, FrieslandCampina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372601
- Sponsor's protocol ID
- Stress Defense
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Galacto-oligosaccharides (GOS) on Self-perceived Stress in Apparently Healthy But Stressed Dutch Women: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05372601
- Acronym / sponsor ID
- Stress Defense
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relax+ | Experimental | Dietary Supplement: Relax+Relax+ consists of a powder containing a blend of two prebiotics. |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinThe placebo contains maltodextrin. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relax+Prebiotics, daily administered | Dietary supplement | Relax+ |
| MaltodextrinPlacebo, daily administered | Dietary supplement | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reina S Tjoelker, MSc principal investigator
FrieslandCampina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relax+ and Maltodextrin in people with Stress, Psychological, run by FrieslandCampina at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.