ClinicalTrials.gg
CompletedNCT03384030MOISTUpdated Sep 5, 2018

Exploration of the Modulation of Skin Microbiota and Odor Components by Introduction of Stress in Healthy Male Subjects

An interventional study of adapted STMST in Emotional Stress, sponsored by NIZO Food Research. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by NIZO Food Research · Not applicable, Interventional, and Basic science

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 34 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Stress, Psychological with a site in Netherlands — 2 open to participants now, 3 under way, none of them phase 3. Stress, Psychological · Netherlands.

Enrollment
9th of 11
30 · median 55
Started
2017
the only one that year
No phase
10 of 13
1 open now
Registered
2nd of 13
by date
Lead sponsor
1 of 13
NIZO Food Research

Among the 13 studies in Stress, Psychological with a site in Netherlands, this one is the 9th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2017, is one of 10 with no phase, and was the 2nd registered.

Stress, Psychological

848 studies on the registry are indexed under Stress, Psychological; 139 are open to participants now.

Browse Stress, Psychological studies →

Open to participants now

2 of the 13 studies in Stress, Psychological with a site in Netherlands are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 75 Stress, Psychological studies recruiting now, 34 (45%) set no upper age limit and 37 (49%) stop at 75 or younger; 14 take children under 18; 49 take healthy volunteers.

This study: 18 Years to 34 Years · male · healthy volunteers too.

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02

Study 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.

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.

03

Conditions studied

  • Emotional Stress

Browse trials for

Keywords

  • Malodor
  • Stress
  • STMST
04

Who can participate

Ages eligible
18 Years to 34 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male;
  2. Age 18-34 yrs;
  3. between 18,5-25 kg/m2;
  4. Healthy as assessed by the NIZO lifestyle and health questionnaire;
  5. Non-smoking;
  6. Signed ;
  7. Malodor score ≥ 4≤ 8 as assessed by malodor judges
  8. Access to internet;
  9. Voluntary participation;
  10. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned;
  11. 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;
  12. 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;
  13. Willing to comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Alcohol consumption > 15 units/week and > 3/day;
  2. Drug abuse;
  3. Former participation in a cognitively challenging computer task or mental performance test;
  4. Heavy exercise or sports training > 10 hours/week;
  5. Hyperhidrosis , Hypohidrosis or Anhidrosis;
  6. Known allergy to cosmetics;
  7. Mental status that is incompatible with the proper conduct of the study;
  8. 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;
  9. Psychiatric disorders;
  10. Use of anti-anxiety medications or beta-blockers, statins or blood pressure medication;
  11. Use of antibiotics during the six (6) months prior to study start;
  12. Use of topical medications in underarm area during 2 weeks prior to study start;
  13. Recurring infections, boils, abscesses or lymph node enlargement in the underarm and ;
  14. Active eczema or psoriasis on any portion of the body.
  15. Personnel of the research institute(s) involved in execution of the study, their partner and their first and second degree relatives;
  16. 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    adapted STMST

    Participants are subjected to the adapted STMST to induce emotional sweating.

    Other: adapted STMST

Interventions

  • Otheradapted STMST

    Participants are subjected to the adapted STMST to induce emotional sweating.

06

What researchers measure

Primary outcomes

  1. stress-induced malodor formation

    Expert assessments of stress-induced malodor formation by emotional stress in the armpits of healthy male volunteers

    Time frame: Change from baseline malodour formation 20 min, 40 min, and 60 minutes after the start of exposure to the adapted STMST

Secondary outcomes

  1. Salivary cortisol

    Emotional stress in healthy male volunteers as assessed by cortisol in saliva

    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

  2. Self-assessed mood state

    Emotional stress in healthy male volunteers as assessed by self-assessed mood state (VAS)

    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

  3. Malodor compounds formation

    The malodor compounds formation as assessed by GC-MS/MS analyses during conditions of emotional sweating

    Time frame: Change from baseline malodour compounds formation 75 minutes after the start of exposure to the adapted STMST

07

Study locations

1 site
  • NIZO
    Ede, Gelderland 6718ZB, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Nov 2017, 0 months.

Of 459 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 0 months is below that.

Counting every sponsor, half of 472 studies reached it within 13 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2017
First posted
Dec 27, 2017
StartActual
Oct 31, 2017
Primary completionActual
Nov 17, 2017
CompletionActual
Mar 17, 2018
Last update
Sep 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03384030
Lead sponsor
NIZO Food Research
Collaborators
Procter and Gamble
Responsible party
Sponsor
First posted
Dec 27, 2017
Start date
Oct 31, 2017
Primary completion
Nov 17, 2017
Completion
Mar 17, 2018
Last update
Sep 5, 2018

Study contacts

Melle van Schaik
study director · NIZO Food Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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