Effects of Exercise and 5-HTP on Cortisol Levels

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Exercise and 5-HTP on Cortisol Levels

Conditions
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Plasma Cortisol

Intervention / Treatment
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* Dietary Supplement: 5-HTP
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-HTP<br>200 mg 5-HTP capsule will be ingested 2h prior to reporting to the laboratory. | Dietary Supplement: 5-HTP<br>* 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<br>|
| Placebo Comparator: Placebo<br>For these visit subjects will ingest placebo (Sugar pill) capsule 2 hours before reporting to the laboratory. | Dietary Supplement: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma cortisol from baseline to 20 minutes post | 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 | baseline, 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma cortisol from baseline to 5 minutes post | 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 | baseline, 5 minutes |