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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03384030
Acronym
MOIST
Enrollment
30
Registered
2017-12-27
Start date
2017-10-31
Completion date
2018-03-17
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Stress

Keywords

Malodor, Stress, STMST

Brief 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.

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.

Interventions

OTHERadapted STMST

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

Sponsors

Procter and Gamble
CollaboratorINDUSTRY
NIZO Food Research
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Subjects will be kept naïve with respect to the fact that stress responses are the primary responses of interest.

Intervention model description

All participants receive the same intervention. 30 healthy males are subjected to the adapted STMST to induce emotional sweating.

Eligibility

Sex/Gender
MALE
Age
18 Years to 34 Years
Healthy volunteers
Yes

Inclusion criteria

1. Male; 2. Age 18-34 yrs; 3. BMI between 18,5-25 kg/m2; 4. Healthy as assessed by the NIZO lifestyle and health questionnaire; 5. Non-smoking; 6. Signed informed consent; 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

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.

Design outcomes

Primary

MeasureTime frameDescription
stress-induced malodor formationChange from baseline malodour formation 20 min, 40 min, and 60 minutes after the start of exposure to the adapted STMSTExpert assessments of stress-induced malodor formation by emotional stress in the armpits of healthy male volunteers

Secondary

MeasureTime frameDescription
Salivary cortisolChange 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 STMSTEmotional stress in healthy male volunteers as assessed by cortisol in saliva
Self-assessed mood stateChange 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 STMSTEmotional stress in healthy male volunteers as assessed by self-assessed mood state (VAS)
Malodor compounds formationChange from baseline malodour compounds formation 75 minutes after the start of exposure to the adapted STMSTThe malodor compounds formation as assessed by GC-MS/MS analyses during conditions of emotional sweating

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026