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Effects of Exercise and 5-HTP on Cortisol Levels

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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

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.

Condition or disease Intervention/treatment Phase
Plasma Cortisol Dietary Supplement: 5-HTP Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Exercise and 5-HTP on Cortisol Levels
Study Start Date : June 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5-HTP
200 mg 5-HTP capsule will be ingested 2h prior to reporting to the laboratory.
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

Placebo Comparator: Placebo
For these visit subjects will ingest placebo (Sugar pill) capsule 2 hours before reporting to the laboratory.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187341


Contacts
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Contact: Pedro Del Corral, PhD-MD 630 8296575 pdelcorral@ben.edu

Locations
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United States, Illinois
Benedictine University Recruiting
Lisle, Illinois, United States, 60532
Principal Investigator: Pedro Del Corral, PhD-MD         
Sponsors and Collaborators
Benedictine University
Investigators
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Principal Investigator: Pedro Del Corral, PhD-MD Benedictine University

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Responsible Party: Benedictine University
ClinicalTrials.gov Identifier: NCT02187341     History of Changes
Other Study ID Numbers: Ben-0614b
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Hydrocortisone
5-Hydroxytryptophan
Anti-Inflammatory Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs