Physiological and Appetitive Effects of CBD Supplementation

Overview

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.

Full Title of Study: “Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: October 1, 2023

Interventions

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

Arms, Groups and Cohorts

• Experimental: CBD
  • 1 mL hemp oil containing 60 mg/mL CBD, daily.
• Placebo Comparator: Placebo
  • 1 mL hemp oil containing 0 mg/mL CBD, daily.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

• CBD
  • Time Frame: Baseline and after 4 weeks supplementation
  • CBD circulating in plasma
• Liver transaminases
  • Time Frame: Baseline and after 4 weeks supplementation
  • AST and ALT circulating in plasma
• Hormones implicated in appetite regulation
  • Time Frame: Baseline and after 4 weeks supplementation
  • Hormones implicated in appetite regulation (e.g., leptin and ghrelin) circulating in plasma
• Lipoproteins
  • Time Frame: Baseline and after 4 weeks supplementation
  • Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma
• Glucose
  • Time Frame: Baseline and after 4 weeks supplementation
  • Glucose circulating in plasma
• Triglycerides
  • Time Frame: Baseline and after 4 weeks supplementation
  • Triglycerides circulating in plasma
• Insulin
  • Time Frame: Baseline and after 4 weeks supplementation
  • Insulin circulating in plasma
• Subjective appetite (hunger, fullness, desire to eat)
  • Time Frame: 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
  • Time Frame: During 4 weeks supplementation
  • Adverse events reported in diary by participants

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Loughborough University
• Collaborator
  • Bridge Farm Nurseries Limited, Spalding, UK
• Provider of Information About this Clinical Study
  • Principal Investigator: Lewis James, Senior Lecturer in Nutrition – Loughborough University
• Overall Contact(s)
  • Lewis J James, PhD, 00441509226305, L.James@lboro.ac.uk