Effects of Fruit Juices on Hormone Metabolism

Cortisol Clinical Trial

Official title:

Effect of Grapefruit Juice and Exercise on Cortisol Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187328
• Other study ID #: Ben-0614a
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2014
• Last updated: July 10, 2014
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Benedictine University
• Contact: Pedro Del Corral, PhD/MD
• Phone: 630 8296575
• Email: pdelcorral[@]ben.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether grapefruit juice alters the metabolism of cortisol following intense exercise.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Young men and women, not taking medications known to alter glucocorticoid metabolism

Exclusion Criteria:

• Diabetes, uncontrolled hypertension, obesity, any medication known to interact with grapefruit juice

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cortisol

Intervention

Other:
• Grapefruit juice
Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only
• Apple juice
Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice or Apple juice ingested in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only

Locations

Country	Name	City	State
United States	Benedictine University	Lisle	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Benedictine University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma cortisol change from baseline at 45 minutes	Plasma cortisol levels will be collected at baseline and 45 minutes post-exercise for the Grapefruit visit intervention and for the Apple juice intervention. The interventions are acute ( 1 day), 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 14 to 30 days.	Baseline, 45 minutes	No
Secondary	Change in plasma cortisol from 15 minutes to baseline	Plasma cortisol levels will be collected at baseline and 15 minutes post-exercise for the Grapefruit visit intervention and for the Apple juice intervention. The interventions are acute ( 1 day), 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 14 to 30 days.	baseline, 15 minutes	No