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

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 Overview

• Status: Completed
• Conditions: Emotional Stress
• Intervention / Treatment: Other: adapted STMST

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Ede, Gelderland, Netherlands, 6718ZB
      • NIZO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adapted STMST; Participants are subjected to the adapted STMST to induce emotional sweating.	Other: adapted STMST; Participants are subjected to the adapted STMST to induce emotional sweating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stress-induced malodor formation	Expert assessments of stress-induced malodor formation by emotional stress in the armpits of healthy male volunteers	Change from baseline malodour formation 20 min, 40 min, and 60 minutes after the start of exposure to the adapted STMST

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cortisol	Emotional stress in healthy male volunteers as assessed by cortisol in saliva	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)	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	Change from baseline malodour compounds formation 75 minutes after the start of exposure to the adapted STMST

Collaborators and Investigators

• Sponsor: NIZO Food Research
• Collaborators: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): March 17, 2018

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Stress; Malodor; STMST
• Other Study ID Numbers: NL62290.041.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No