Emotional StressMOISTNCT03384030
Exploration of the Modulation of Skin Microbiota and Odor Components by Introduction of Stress in Healthy Male Subjects
A study testing adapted STMST in people with Emotional Stress, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
In the MOIST study it will be assessed whether the adapted Sternberg short-term working memory task (STMST) is an effective method to induce malodor formation by emotional stress, as assessed by expert assessments of stress-induced malodor formation in the armpits of 30 healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress
- What is being tested?
- adapted STMST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Oct 2017to 17 Mar 2018
- 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 18 to 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male;
- Age 18-34 yrs;
- BMI between 18,5-25 kg/m2;
- Healthy as assessed by the NIZO lifestyle and health questionnaire;
- Non-smoking;
- Signed informed consent;
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- Malodor score ≥ 4≤ 8 as assessed by malodor judges
- Access to internet;
- Voluntary participation;
- Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned;
- Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for the study for at least 15 years;
- Willing to accept information-transfer concerning participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
- Willing to comply with study procedures.
Who cannot join
- Alcohol consumption > 15 units/week and > 3/day;
- Drug abuse;
- Former participation in a cognitively challenging computer task or mental performance test;
- Heavy exercise or sports training > 10 hours/week;
- Hyperhidrosis , Hypohidrosis or Anhidrosis;
- Known allergy to cosmetics;
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- Mental status that is incompatible with the proper conduct of the study;
- Participation in any scientific study with oral, intravenous or inhalatory administration of any substances during two (2) months before study start that could interfere with the MOIST study;
- Psychiatric disorders;
- Use of anti-anxiety medications or beta-blockers, statins or blood pressure medication;
- Use of antibiotics during the six (6) months prior to study start;
- Use of topical medications in underarm area during 2 weeks prior to study start;
- Recurring infections, boils, abscesses or lymph node enlargement in the underarm and ;
- Active eczema or psoriasis on any portion of the body.
- Personnel of the research institute(s) involved in execution of the study, their partner and their first and second degree relatives;
- Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results.
Trial locations and contacts
1 site in 1 country.
About this study
In the MOIST study it will be assessed whether the adapted Sternberg short-term working memory task (STMST) is an effective method to induce malodor formation by emotional stress, as assessed by expert assessments of stress-induced malodor formation in the armpits of 30 healthy male volunteers.
Before, during and after being exposed to the adapted version of the STMST, saliva will be collected to determine cortisol levels, subjects have to rate their momentary feelings of anxiety and embarrassment and heart rate variability will be monitored continuously with a wireless signal transmission device. Before and after exposure to the adapted STMST, malodor levels will be assessed by two expert judges, axillary volatiles will be collected by cup scrubbing and microbiota samples will be taken to determine microbial species.
Read the detailed description
Stress is a primary physiological response to physical and/or social threats resulting from a complex interplay of neurophysiological and psychological factors. Cognitive interpretations of social-evaluative threats have been found to be very potent emotional stressors. Apocrine sweat glands are stimulated by emotional stress, fear or mental tension. Upon secretion, apocrine sweat is odorless. By enzymatic action of the bacterial microbiome on apocrine sweat in particular, body malodor is formed. This is perceived as offensive by most societies. As a result, self-confidence and social relationships can be influenced by undesired body odor. A good understanding of the complex sweat-microbiome interactions leading to malodor formation is required for the development of effective malodor remedies.
In the MOIST study it will be assessed whether the adapted Sternberg short-term working memory task (STMST) is an effective method to induce malodor formation by emotional stress, as assessed by expert assessments of stress-induced malodor formation in the armpits of 30 healthy male volunteers.
Before, during and after being exposed to the adapted version of the STMST, saliva will be collected to determine cortisol levels, subjects have to rate their momentary feelings of anxiety and embarrassment and heart rate variability will be monitored continuously with a wireless signal transmission device. Before and after exposure to the adapted STMST, malodor levels will be assessed by two expert judges, axillary volatiles will be collected by cup scrubbing and microbiota samples will be taken to determine microbial species.
- Conditions
- Emotional Stress
- Being tested
- adapted STMST
- Keywords
- Malodor, Stress, STMST
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted STMSTOther
Participants are subjected to the adapted STMST to induce emotional sweating.
| Study group | Role | What they receive |
|---|---|---|
| adapted STMST | Experimental | Participants are subjected to the adapted STMST to induce emotional sweating. Receives: Other: adapted STMST |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress-induced malodor formation
Expert assessments of stress-induced malodor formation by emotional stress in the armpits of healthy male volunteers
Measured: Change from baseline malodour formation 20 min, 40 min, and 60 minutes after the start of exposure to the adapted STMST
Secondary outcomes (3)
Salivary cortisol
Emotional stress in healthy male volunteers as assessed by cortisol in saliva
Measured: Change from baseline salivary cortisol 5 min, 20 min, 30 min, 40 min, 50 min, 60 min, and 70 minutes after the start of exposure to the adapted STMST
Self-assessed mood state
Emotional stress in healthy male volunteers as assessed by self-assessed mood state (VAS)
Measured: Change from baseline self-assessed mood state 5 min, 20 min, 30 min, 40 min, 50 min, 60 min, 70 min, and 90 minutes after the start of exposure to the adapted STMST
Malodor compounds formation
The malodor compounds formation as assessed by GC-MS/MS analyses during conditions of emotional sweating
Measured: Change from baseline malodour compounds formation 75 minutes after the start of exposure to the adapted STMST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start31 Oct 2017
- Primary completion17 Nov 2017
- Study completion17 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention. 30 healthy males are subjected to the adapted STMST to induce emotional sweating.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Melle van Schaik, Study director, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384030
- Sponsor's protocol ID
- NL62290.041.17
- Acronym
- MOIST
- Status last verified
- Dec 2017
- First submitted
- 7 Nov 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Modulation of Skin Microbiota and Odor Components by Introduction of Stress in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03384030
- Acronym / sponsor ID
- MOIST / NL62290.041.17
- Conditions
- Emotional Stress
- Keywords
- Malodor, Stress, STMST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Mar 2018 (actual)
- First posted
- 27 Dec 2017 (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 the MOIST study it will be assessed whether the adapted Sternberg short-term working memory task (STMST) is an effective method to induce malodor formation by emotional stress, as assessed by expert assessments of stress-induced malodor formation in the armpits of 30 healthy male volunteers.
Before, during and after being exposed to the adapted version of the STMST, saliva will be collected to determine cortisol levels, subjects have to rate their momentary feelings of anxiety and embarrassment and heart rate variability will be monitored continuously with a wireless signal transmission device. Before and after exposure to the adapted STMST, malodor levels will be assessed by two expert judges, axillary volatiles will be collected by cup scrubbing and microbiota samples will be taken to determine microbial species.
Detailed description
Stress is a primary physiological response to physical and/or social threats resulting from a complex interplay of neurophysiological and psychological factors. Cognitive interpretations of social-evaluative threats have been found to be very potent emotional stressors. Apocrine sweat glands are stimulated by emotional stress, fear or mental tension. Upon secretion, apocrine sweat is odorless. By enzymatic action of the bacterial microbiome on apocrine sweat in particular, body malodor is formed. This is perceived as offensive by most societies. As a result, self-confidence and social relationships can be influenced by undesired body odor. A good understanding of the complex sweat-microbiome interactions leading to malodor formation is required for the development of effective malodor remedies.
In the MOIST study it will be assessed whether the adapted Sternberg short-term working memory task (STMST) is an effective method to induce malodor formation by emotional stress, as assessed by expert assessments of stress-induced malodor formation in the armpits of 30 healthy male volunteers.
Before, during and after being exposed to the adapted version of the STMST, saliva will be collected to determine cortisol levels, subjects have to rate their momentary feelings of anxiety and embarrassment and heart rate variability will be monitored continuously with a wireless signal transmission device. Before and after exposure to the adapted STMST, malodor levels will be assessed by two expert judges, axillary volatiles will be collected by cup scrubbing and microbiota samples will be taken to determine microbial species.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention. 30 healthy males are subjected to the adapted STMST to induce emotional sweating.
| Arm | Type | Receives |
|---|---|---|
| adapted STMST | Experimental | Other: adapted STMSTParticipants are subjected to the adapted STMST to induce emotional sweating. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male;
- Age 18-34 yrs;
- BMI between 18,5-25 kg/m2;
- Healthy as assessed by the NIZO lifestyle and health questionnaire;
- Non-smoking;
Key exclusion criteria (16 listed)
- Alcohol consumption > 15 units/week and > 3/day;
- Drug abuse;
- Former participation in a cognitively challenging computer task or mental performance test;
- Heavy exercise or sports training > 10 hours/week;
- Hyperhidrosis , Hypohidrosis or Anhidrosis;
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 |
|---|---|---|
| adapted STMSTParticipants are subjected to the adapted STMST to induce emotional sweating. | Other | adapted STMST |
Primary outcome
stress-induced malodor formation
Time frame: Change from baseline malodour formation 20 min, 40 min, and 60 minutes after the start of exposure to the adapted STMST
Expert assessments of stress-induced malodor formation by emotional stress in the armpits of healthy male volunteers
3 secondary outcomes
Salivary cortisol
Time frame: Change from baseline salivary cortisol 5 min, 20 min, 30 min, 40 min, 50 min, 60 min, and 70 minutes after the start of exposure to the adapted STMST
Self-assessed mood state
Time frame: Change from baseline self-assessed mood state 5 min, 20 min, 30 min, 40 min, 50 min, 60 min, 70 min, and 90 minutes after the start of exposure to the adapted STMST
Malodor compounds formation
Time frame: Change from baseline malodour compounds formation 75 minutes after the start of exposure to the adapted STMST
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 5 Sep 2018.
- 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.
Melle van Schaik study director
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted STMST in people with Emotional Stress, run by NIZO Food Research 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 13 inclusion and 16 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 5 Sep 2018. 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. 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?
stress-induced malodor formation (time frame: Change from baseline malodour formation 20 min, 40 min, and 60 minutes after the start of exposure to the adapted STMST). 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 5 Sep 2018.