Physiological and Appetitive Effects of CBD Supplementation

Not Applicable

Recruiting

• Conditions: Appetitive Behavior; Metabolic Health; Adverse Effect
• Interventions: Dietary Supplement: Cannabidiol (CBD) supplementation; Dietary Supplement: Placebo supplementation

• Registration Number: NCT05774574
• Lead Sponsor: Loughborough University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Study Start: 2023-01-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-10-01
• Study Completion: 2024-01-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males and females, aged 18-50, who do not meet the exclusion criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBD	Cannabidiol (CBD) supplementation	1 mL hemp oil containing 60 mg/mL CBD, daily.
Placebo	Placebo supplementation	1 mL hemp oil containing 0 mg/mL CBD, daily.

Primary Outcome Measures

Name	Time	Method
Energy Intake	Baseline and after 4 weeks supplementation	Self-selected energy intake at an ad libitum mixed meal

Secondary Outcome Measures

Name	Time	Method
Glucose	Baseline and after 4 weeks supplementation	Glucose circulating in plasma
Lipoproteins	Baseline and after 4 weeks supplementation	Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma
Insulin	Baseline and after 4 weeks supplementation	Insulin circulating in plasma
CBD	Baseline and after 4 weeks supplementation	CBD circulating in plasma
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
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

Trial Locations

Locations (1)

Loughborough University; 🇬🇧 Loughborough, Leicestershire, United Kingdom