Physiological and Appetitive Effects of CBD Supplementation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Appetitive Behavior; Adverse Effect; Metabolic Health
• Intervention / Treatment: Dietary supplement: Cannabidiol (CBD) supplementation; Dietary supplement: Placebo supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lewis J James, PhD; Phone Number: 00441509226305; Email: L.James@lboro.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE113TU
      • Recruiting
      • Loughborough University
      • Contact: Lewis J James, PhD; Phone Number: 00441509226305; Email: L.James@lboro.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD; 1 mL hemp oil containing 60 mg/mL CBD, daily.	Dietary supplement: Cannabidiol (CBD) supplementation; Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally
Placebo Comparator: Placebo; 1 mL hemp oil containing 0 mg/mL CBD, daily.	Dietary supplement: Placebo supplementation; Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Loughborough University
• Collaborators: Bridge Farm Nurseries Limited, Spalding, UK

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): January 5, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 11031 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual data for study outcomes will be shared on the Loughborough University Research Repository
• IPD Sharing Time Frame: Permanently, after publication of study findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No