Effects of Fruit Juices on Hormone Metabolism

NCT02187328 | Unknown

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

Brief Summary

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

Conditions

Cortisol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in plasma cortisol from 15 minutes to baseline

  baseline, 15 minutes

Study Arms (2)

Grapefruit juice

EXPERIMENTAL

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

Apple juice

PLACEBO COMPARATOR

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

Interventions

Grapefruit juice OTHER

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

Grapefruit juice

Apple juice OTHER

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

Apple juice

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benedictine University: lead

Study Sites (1)

Benedictine University

Lisle, Illinois, 60532, United States

RECRUITING

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: NONE
• Purpose: BASIC SCIENCE
• 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)