Effects of Exercise and 5-HTP on Cortisol Levels

NCT02187341 | Unknown

• 1 other identifier: Ben-0614b
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Cortisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in plasma cortisol from baseline to 5 minutes post

  baseline, 5 minutes

Study Arms (2)

5-HTP

EXPERIMENTAL

200 mg 5-HTP capsule will be ingested 2h prior to reporting to the laboratory.

Dietary Supplement: 5-HTP

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

5-HTP DIETARY_SUPPLEMENT

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

5-HTP

Placebo DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benedictine University: lead

Study Sites (1)

Benedictine University

Lisle, Illinois, 60532, United States

RECRUITING

MeSH Terms

Interventions

5-Hydroxytryptophan

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pedro Del Corral, PhD-MD

  Benedictine University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Del Corral, PhD-MD

CONTACT

630 8296575; pdelcorral@ben.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 11, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

US (1)