Status:

COMPLETED

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

Lead Sponsor:

NIZO Food Research

Collaborating Sponsors:

Procter and Gamble

Conditions:

Emotional Stress

Eligibility:

MALE

18-34 years

Phase:

NA

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 exper...

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-eva...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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;
  • 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.

Key Trial Info

Start Date :

October 31 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 17 2018

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03384030

Start Date

October 31 2017

End Date

March 17 2018

Last Update

September 5 2018

Active Locations (1)

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NIZO

Ede, Gelderland, Netherlands, 6718ZB