Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Exercise and 5-HTP on Cortisol Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187341
Recruitment Status : Unknown
Verified July 2014 by Benedictine University.
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Benedictine University

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date July 11, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Change in plasma cortisol from baseline to 20 minutes post [ Time Frame: baseline, 20 min ]
Plasma cortisol will be assessed at baseline and 20 min post exercise and compared to baseline, and compared between treatments: 5-HTP vs placebo visit. The interventions are acute ( 1 dose, 1 day), for 5-HTP and for placebo, there is no follow up. The interventions are at least 1 week apart. For a given subject, the estimated time for study completion for the 2 treatments is 10 to 30 days
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Change in plasma cortisol from baseline to 5 minutes post [ Time Frame: baseline, 5 minutes ]
Plasma cortisol will be assessed at baseline and 5 min post exercise and compared to baseline, and compared between treatments: 5-HTP vs placebo visit. The interventions are acute ( 1 dose, 1 day), for 5-HTP and for placebo, there is no follow up. The interventions are at least 1 week apart. For a given subject, the estimated time for study completion for the 2 treatments is 10 to 30 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Exercise and 5-HTP on Cortisol Levels
Official Title  ICMJE Effects of Exercise and 5-HTP on Cortisol Levels
Brief Summary It has been shown that 5-HTP stimulates cortisol levels in plasma and saliva. Similarly, it has been shown that intense exercise stimulates an increase in plasma and salivary cortisol levels. The purpose of this study is to examine the combined effects of 5-HTP + intense exercise on plasma and salivary cortisol levels.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Plasma Cortisol
Intervention  ICMJE
  • Dietary Supplement: 5-HTP
    Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized
  • Dietary Supplement: Placebo
    Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized
Study Arms  ICMJE
  • Experimental: 5-HTP
    200 mg 5-HTP capsule will be ingested 2h prior to reporting to the laboratory.
    Intervention: Dietary Supplement: 5-HTP
  • Placebo Comparator: Placebo
    For these visit subjects will ingest placebo (Sugar pill) capsule 2 hours before reporting to the laboratory.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men and women, not taking medication known to alter glucocorticoid metabolism

Exclusion Criteria:

  • Diabetes
  • Obesity
  • Hypertension
  • Coronary artery disease
  • Psychiatric disorders
  • Any disease preventing them from participating in intense exercise
  • Subjects taking medication known to interfere with glucocorticoid metabolism will be excluded
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187341
Other Study ID Numbers  ICMJE Ben-0614b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benedictine University
Study Sponsor  ICMJE Benedictine University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pedro Del Corral, PhD-MD Benedictine University
PRS Account Benedictine University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP