Physiological and Appetitive Effects of CBD Supplementation

Appetitive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774574
• Other study ID #: 11031
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: March 2023
• Source: Loughborough University
• Contact: Lewis J James, PhD
• Phone: 00441509226305
• Email: L.James[@]lboro.ac.uk
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 5, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effect
• Appetitive Behavior
• Metabolic Health

Intervention

Dietary Supplement:
• Cannabidiol (CBD) supplementation
Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally
• Placebo supplementation
Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
Loughborough University	Bridge Farm Nurseries Limited, Spalding, UK

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	Baseline and after 4 weeks supplementation
Secondary	CBD	CBD circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	Liver transaminases	AST and ALT circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	Hormones implicated in appetite regulation	Hormones implicated in appetite regulation (e.g., leptin and ghrelin) circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	Lipoproteins	Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	Glucose	Glucose circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	Triglycerides	Triglycerides circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	Insulin	Insulin circulating in plasma	Baseline and after 4 weeks supplementation
Secondary	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
Secondary	self-reported adverse events	Adverse events reported in diary by participants	During 4 weeks supplementation