Physiological and Appetitive Effects of CBD Supplementation

Study Overview
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Brief Summary
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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.

Official Title
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Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population

Conditions
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Appetitive Behavior, Adverse Effect, Metabolic Health

Intervention / Treatment
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* Dietary Supplement: Cannabidiol (CBD) supplementation
* Dietary Supplement: Placebo supplementation


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD<br>1 mL hemp oil containing 60 mg/mL CBD, daily. | Dietary Supplement: Cannabidiol (CBD) supplementation<br>* Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally<br>|
| Placebo Comparator: Placebo<br>1 mL hemp oil containing 0 mg/mL CBD, daily. | Dietary Supplement: Placebo supplementation<br>* Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Intake | Self-selected energy intake at an ad libitum mixed meal | Baseline and after 4 weeks supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBD | CBD circulating in plasma | Baseline and after 4 weeks supplementation | 
| Liver transaminases | AST and ALT circulating in plasma | Baseline and after 4 weeks supplementation | 
| Hormones implicated in appetite regulation | Hormones implicated in appetite regulation (e.g., leptin and ghrelin) circulating in plasma | Baseline and after 4 weeks supplementation | 
| Lipoproteins | Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma | Baseline and after 4 weeks supplementation | 
| Glucose | Glucose circulating in plasma | Baseline and after 4 weeks supplementation | 
| Triglycerides | Triglycerides circulating in plasma | Baseline and after 4 weeks supplementation | 
| Insulin | Insulin circulating in plasma | Baseline and after 4 weeks supplementation | 
| Subjective appetite (hunger, fullness, desire to eat) | Measured using pen and paper scales (scored 'not at all' [0 mm] to 'extremely' [100 mm]) | Baseline and after 4 weeks supplementation | 
| self-reported adverse events | Adverse events reported in diary by participants | During 4 weeks supplementation |