CortisolNCT02187328
Effects of Fruit Juices on Hormone Metabolism
A study testing Grapefruit juice and Apple juice in people with Cortisol, run by Benedictine University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether grapefruit juice alters the metabolism of cortisol following intense exercise. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cortisol
- What is being tested?
- Grapefruit juice and Apple juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young men and women, not taking medications known to alter glucocorticoid metabolism
Who cannot join
- Diabetes, uncontrolled hypertension, obesity, any medication known to interact with grapefruit juice
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Benedictine University
Lisle, Illinois, 60532
Meagan P Daniels, madaniel@ben.edu
Pedro Del Corral, PhD-MD
About this study
Official title: 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.
- Conditions
- Cortisol
- Being tested
- Grapefruit juice, Apple juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grapefruit juiceOther
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 juiceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 45 minutes
Secondary outcomes (1)
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.
Measured: baseline, 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CortisolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benedictine University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Del Corral, PhD-MD, Principal investigator, Benedictine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187328
- Sponsor's protocol ID
- Ben-0614a
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Grapefruit Juice and Exercise on Cortisol Levels
- ClinicalTrials.gov ID
- NCT02187328
- Acronym / sponsor ID
- Ben-0614a
- Conditions
- Cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Benedictine UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether grapefruit juice alters the metabolism of cortisol following intense exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grapefruit juice | Experimental | Other: Grapefruit juice12.5 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 |
| Apple juice | Placebo comparator | Other: Apple juice10.5 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young men and women, not taking medications known to alter glucocorticoid metabolism
Key exclusion criteria (1 listed)
- Diabetes, uncontrolled hypertension, obesity, any medication known to interact with grapefruit juice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grapefruit juiceVolunteers 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 | Other | Grapefruit juice |
| Apple juiceVolunteers 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 | Other | Apple juice |
Primary outcome
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.
1 secondary outcome
Change in plasma cortisol from 15 minutes to baseline
Time frame: baseline, 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Del Corral, PhD-MD principal investigator
Benedictine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grapefruit juice and Apple juice in people with Cortisol, run by Benedictine University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Del Corral, PhD/MD (630 8296575, pdelcorral@ben.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma cortisol change from baseline at 45 minutes (time frame: Baseline, 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.