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DHB Supplement Interaction Study

NCT02257879 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-04-24

No results posted yet for this study

Summary

Background:

\- Drinking grapefruit juice changes how long it takes some medicines to be broken down in the body. Researchers have found that a substance in grapefruit juice called DHB contributes to this effect. Some dietary supplements contain DHB and claim to increase the absorption of any and all supplements, medicine or any other drug. But these usually contain a lot more DHB than a glass of grapefruit juice. Researchers want to study the effects of grapefruit juice and supplements with DHB.

Objective:

\- To compare how a certain dietary supplement (sold as DHB-300 ) versus grapefruit juice affects how long it takes a person s body to break down medicines.

Eligibility:

\- Healthy volunteers ages 18 - 60.

Design:

* Participants will be screened with medical history, physical exam, and blood and urine tests.
* Participants will have 3 treatment visits. Participants cannot drive themselves home from the visits. Each visit lasts about 13.5 hours and includes:
* Questions about medications and participant s health.
* Vital signs taken.
* A finger probe to measure oxygen.
* Blood and urine sampling throughout the visit.
* An IV line inserted into an arm vein. It will stay there throughout the visit.
* Study treatments:
* Midazolam hydrochloride a syrup given to make people sleepy.
* Loperamide a tablet for treating diarrhea.
* 1 glass of water, 1 glass of grapefruit juice, or 1 pill of DHB-300. A different one will be given at each treatment visit.
* One week before each visit, participants cannot have certain fruits and juices. They must fast the night before each visit.
* For the 3 days after each visit, participants will return to the clinic 4 times. Their vital signs will be checked and blood will be drawn.

Conditions

  • Healthy Volunteers

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Shepherd H Schurman, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-03
Primary Completion
2020-04-20
Completion
2020-04-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257879 on ClinicalTrials.gov