CBD, Nutrient Metabolism and Energy Intake

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 a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.

Official Title
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Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults

Conditions
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Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorders, Appetitive Behavior

Intervention / Treatment
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* Dietary Supplement: Acute oral CBD supplementation
* Dietary Supplement: Acute oral placebo supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and <30.0 Exclusion Criteria: Currently engage in >10 hours moderate or vigorous intensity physical activity per week Have consumed CBD or cannabis at all within the past two months Have used CBD or cannabis regularly (>2x in a week) within the past four months Are suffering from any clinically significant illness Have regularly used tobacco within the previous 6 months (> 2/week) 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 provided during the study

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol<br>300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules. | Dietary Supplement: Acute oral CBD supplementation<br>* 1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.<br>|
| Placebo Comparator: Placebo<br>1 ml hemp oil. Provided orally in gelatin capsules. | Dietary Supplement: Acute oral placebo supplementation<br>* 1 ml hemp oil containing no CBD, within gelatin capsules, ingested 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 |  5-30 minutes (time taken to eat a single meal) | 
| Postprandial Glycaemia | Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve) | 3 hours | 
| Postprandial Triglyceridaemia | Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve) | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Insulinaemia | Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve) | 3 hours |