CBD, Nutrient Metabolism and Energy Intake

Appetitive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05618756
• Other study ID #: 5553
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2023
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 31, 2023
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• Acute oral CBD supplementation
1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.
• Acute oral placebo supplementation
1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy intake	Self-selected energy intake at an ad libitum mixed meal	~5-30 minutes (time taken to eat a single meal)
Primary	Postprandial Glycaemia	Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)	3 hours
Primary	Postprandial Triglyceridaemia	Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)	3 hours
Secondary	Postprandial Insulinaemia	Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)	3 hours