Effects of Fruit Juices on Hormone Metabolism

July 10, 2014 updated by: Benedictine University

Effect of Grapefruit Juice and Exercise on Cortisol Levels

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Benedictine University
        • Principal Investigator:
          • Pedro Del Corral, PhD-MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grapefruit juice
12.5 OZ Grapefruit juice: Subject will ingest grapefruit juice 12.5 OZ twice on the day of their scheduled laboratory visit. Once in the morning and once in the afternoon prior to their evening visit
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
Placebo Comparator: Apple juice
10.5 OZ Apple juice: Subject will ingest apple juice 10.5 OZ twice on the day of their scheduled laboratory visit. Once in the morning and once in the afternoon 3 hours prior to their evening visit.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma cortisol change from baseline at 45 minutes
Time Frame: Baseline, 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma cortisol from 15 minutes to baseline
Time Frame: baseline, 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benedictine University

Investigators

  • Principal Investigator: Pedro Del Corral, PhD-MD, Benedictine University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Ben-0614a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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