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

NCT03384030 | Completed

• 1 other identifier: NL62290.041.17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Stress

Keywords

Malodor; Stress; STMST

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Salivary cortisol

  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

  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

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

Study Arms (1)

adapted STMST

EXPERIMENTAL

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

Other: adapted STMST

Interventions

adapted STMST OTHER

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

adapted STMST

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Gender identity is self-reported by the subjects through a questionnaire.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• NIZO Food Research: lead
• Procter and Gamble: collaborator

Study Sites (1)

NIZO

Ede, Gelderland, 6718ZB, Netherlands

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Melle van Schaik

  NIZO Food Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects will be kept naïve with respect to the fact that stress responses are the primary responses of interest.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: December 27, 2017
• Study Start: October 31, 2017
• Primary Completion: November 17, 2017
• Study Completion: March 17, 2018
• Last Updated: September 5, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)