DHB Supplement Interaction Study

Withdrawn before enrolling

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02257879

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

0

Starts

2014-10-03

Expected to finish

2020-04-20

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Women who are currently pregnant or breastfeeding
• Current use of known CYP3A inhibitors or inducers, which in the opinion of the Investigator poses an unacceptable risk to the patient or to the validity of study results. Candidates will be asked about medication use during the screening process and on the day of the exposure visits. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
• Known liver dysfunction or disease as defined by:
• ALT - higher than the normative value and/or determined abnormal by the PI
• AST higher than the normative value and/or determined abnormal by the PI
• ALP higher than the normative value and/or determined abnormal by the PI
• Known kidney dysfunction or disease or:
• Estimated Glomerular Filtration Rate (eGFR)- <60 ml/min per the MDRD equation
• Heart disease
• Pre-existing and known history of psychiatric disorders
• Known history of Myasthenia gravis
• Current use of quinidine, ritonavir, and saquinavir (potential interaction with loperamide)
• Current use of study drug-related medications (benzodiazepines, opioids, herbal supplements; temporary discontinuation per the investigator s discretion may be allowed). Candidates will be asked about medication use during the screening process and also during each of their exposure visits. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
• Known allergy or hypersensitivity to any study treatments (i.e., to GFJ, DHB, midazolam, loperamide, green, black or white pepper, and -Indian Gooseberry),any opioids, or benzodiazepines
• History of acute-angle glaucoma
• History of sleep apnea
• Current diagnosis of anemia, as defined by hemoglobin concentration <13 g/dL for males and hemoglobin concentration <11 g/dL for females or hematocrit values (determined by lancet-induced drop of blood from the fingertip or via clinical labs) Hematocrit must be at least 34% for women and 36% for men on every visit.
• Blood donation within the past 8 weeks of the exposure visit.
• Use of medications for which consumption of GFJ is contraindicated and which in the opinion of the Investigator would pose an unacceptable risk to the patient if discontinued or continued while consuming GFJ. Candidates will be asked about medication use during the screening process. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
• Any other conditions or substance use that in the opinion of the Investigator would pose an unacceptable risk to the patient or to the validity of the study results. Candidates will be asked about health conditions during the screening process. The collected data will be reviewed by the PI or designee to confirm the candidates eligibility.
• BMI >35.

Where it is running

• NIEHS Clinical Research Unit (CRU) — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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