To determine the pharmacokinetics of CBD and its main metabolites following a single, oral dose of a novel, oil-based hemp extract containing 70 mg CBD, administered to healthy volunteers in fasting and fed condition.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
kinetiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The plasma-time curve of CBD (quantitively) and 2 of its metabolites
(semi-quantitatively) after intake of the Becanex natural hemp extract. These
data will be evaluated studied applying descriptive pharmacokinetic analysis
(maximum peak height (Cmax), time-to-peak (Tmax), Half-life (T1/2) and
area-under-the-curve (AUC)). Relative bioavailability in the fed versus fasted
state will be determined by dividing individual AUC values.
Secondary outcome
The differences in CBD kinetics will be determined between men and women
Background summary
Cannabidiol (CBD) is a non-hallucinogenic plant compound of Cannabis sativa L.
and has gained attention for its potential health purposes, favorable safety
profile and low abuse potential. Mainly sold as food supplements,
CBD-containing preparations of different composition, concentration and quality
are widely available in the Netherlands via druggist stores or via Internet.
However, CBD- containing preparations do not yet have a novel food status and
most EU countries are currently applying a tolerance policy for CBD present in-
or derived from hemp products low in THC. Likewise, there are no approved
health claims for CBD, which leads to a situation that products sold by
official drugstores do not contain any indication for use. Last but not least,
products are not subject to any official quality control which creates a
situation that consumers are unaware of the CBD content and potential
contamination of the product they purchase. Getting novel food status would an
important step in better regulation. Such a procedure requires a
well-documented safety assessment. As part of this assessment the
pharmacokinetics of CBD need to be assessed. The aim of the present study is
therefore to investigate the pharmacokinetics of CBD after single oral
administration of a full-spectrum hemp extract. As fatty food is reported to
increase CBD oral bioavailability, we will also study the effect of a high-fat
meal.
Study objective
To determine the pharmacokinetics of CBD and its main metabolites following a
single, oral dose of a novel, oil-based hemp extract containing 70 mg CBD,
administered to healthy volunteers in fasting and fed condition.
Study design
A single dose randomized crossover intervention study
Intervention
In a random order research subjects receive a single dose of hemp extract
containing 70 mg CBD in soft gel capsules in a fasting state and with a
high-fat meal.
Study burden and risks
During the study, research subjects will visit the research facilities for an
information meeting and screening, two test days, including a short visit 24
hours and 48 hours after intake of the test product. During the test days the
research subjects remain at the facilities for 12 hours after intake of the
test product. The research subjects arrive fasted and are allowed to eat only
the provided meals. During the 12 hours they wear a catheter for blood drawing,
this can cause bruising and is uncomfortable. All in all the test days will be
a considerable burden for the research subjects. Although not expected from the
negligible amount of THC and low dose of CBD, ingestion of the hemp extract
could cause mild adverse effects like drowsiness, abdominal discomfort and
increased appetite. Subjects will not directly benefit from the study. They
will receive a financial compensation of ยค295.
Stippeneng 4
Wageningen 6708PB
NL
Stippeneng 4
Wageningen 6708PB
NL
Listed location countries
Age
Inclusion criteria
- - BMI between 18,5 and 25 kg/m2
- Age between 18 and 60 years
- Weight above 50 kg
- Good general health (based on general health questionnaire)
- Veins suitable for blood sampling
- Able to speak Dutch
- Pertinent willingness to abstain from using any hemp product (including
recreational Cannabis) 2 weeks prior and the entire study period.
- (If applicable) In case of using contraceptives, not willing to delay the
break between two packets of the conception pill during which a woman gets her
period during the study period.
Exclusion criteria
- Is currently suffering from a disease
- Has had a psychosis or a family history of psychosis
- Has had any gastrointestinal condition/disease within the 3 months prior to
the intervention
- Haemoglobin (Hb) level < 8.5 mmol/L for men and < 7.5 for women
- Has used medication in the two months before and/or during the intervention.
Oral contraceptives and occasional use of NSAIDs or paracetamol (on average) is allowed.
- Reported weight loss or weight gain of > 2 kg in the month prior to the
intervention
- Use of herbal dietary supplements (excluding vitamins and minerals) or
grapefruit products, 2 weeks before the first testday and in between the
testdays.
- Allergic to products that are provided as part of the standardised diet
- Following a specific diet (e.g. vegetarian, gluten free)
- (History of) drug abuse, in this case meaning >1 x per month use of
recreational drugs
- Cannabis use in the 14 days preceding the first test day.
- Smoking
- Alcohol consumption of >10 standardised glasses per week.
- Recent or planned blood donation (<3 month prior to first study day or during
intervention)
- Have been pregnant or breastfeeding in the last 6 months, or plan to become
pregnant during the study
- Personnel or MSc thesis student of Wageningen University, department of Human
Nutrition and Health,
- Currently participating in other research or was participating in another
study within 1 month of the intervention or within 3 months if invasive
procedures were used.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04589455 |
| CCMO | NL74963.041.21 |