Adverse Effect, Appetitive Behavior, Metabolic Health
Conditions
Brief summary
CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite regulation and metabolic health. Healthy, adult volunteers will be assigned to placebo or CBD supplementation, in a randomized controlled trial, comparing changes in outcomes across the supplementation period between groups.
Interventions
DIETARY_SUPPLEMENTCannabidiol (CBD) supplementation
Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally
DIETARY_SUPPLEMENTPlacebo supplementation
Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally
Sponsors
Bridge Farm Nurseries Limited, Spalding, UK
Loughborough University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Exclusion criteria
* No history of any substance abuse * Have used tobacco regularly (\>2x in a week) within the past 6 months * Are suffering from any condition that may affect study outcomes * Currently use any prescription or over-the-counter medications (except for hormonal contraception and simple painkillers) * Have given a standard blood donation within 30 days of screening * Are currently pregnant or lactating * Are allergic/intolerant to any ingredients in food items we provide during the study (relevant allergens: oats, milk) Inclusion Criteria: * Males and females, aged 18-50, who do not meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy Intake | Baseline and after 4 weeks supplementation | Self-selected energy intake at an ad libitum mixed meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver transaminases | Baseline and after 4 weeks supplementation | AST and ALT circulating in plasma |
| Hormones implicated in appetite regulation | Baseline and after 4 weeks supplementation | Hormones implicated in appetite regulation (e.g., leptin and ghrelin) circulating in plasma |
| Lipoproteins | Baseline and after 4 weeks supplementation | Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma |
| Glucose | Baseline and after 4 weeks supplementation | Glucose circulating in plasma |
| CBD | Baseline and after 4 weeks supplementation | CBD circulating in plasma |
| Insulin | Baseline and after 4 weeks supplementation | Insulin circulating in plasma |
| Subjective appetite (hunger, fullness, desire to eat) | Baseline and after 4 weeks supplementation | Measured using pen and paper scales (scored 'not at all' \[0 mm\] to 'extremely' \[100 mm\]) |
| self-reported adverse events | During 4 weeks supplementation | Adverse events reported in diary by participants |
| Triglycerides | Baseline and after 4 weeks supplementation | Triglycerides circulating in plasma |
Countries
United Kingdom
Contacts
Primary ContactLewis J James, PhD
Outcome results
None listed