Physiological and Appetitive Effects of CBD Supplementation

NCT05774574 | Unknown

• 1 other identifier: 11031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior; Adverse Effect; Metabolic Health

Outcome Measures

Primary Outcomes (1)

• Energy Intake

  Self-selected energy intake at an ad libitum mixed meal

  Baseline and after 4 weeks supplementation

Secondary Outcomes (9)

• CBD

  Baseline and after 4 weeks supplementation

• Liver transaminases

  Baseline and after 4 weeks supplementation

• Hormones implicated in appetite regulation

  Baseline and after 4 weeks supplementation

• Lipoproteins

  Baseline and after 4 weeks supplementation

• Glucose

  Baseline and after 4 weeks supplementation

Study Arms (2)

CBD

EXPERIMENTAL

1 mL hemp oil containing 60 mg/mL CBD, daily.

Dietary Supplement: Cannabidiol (CBD) supplementation

Placebo

PLACEBO COMPARATOR

1 mL hemp oil containing 0 mg/mL CBD, daily.

Dietary Supplement: Placebo supplementation

Interventions

Cannabidiol (CBD) supplementation DIETARY_SUPPLEMENT

Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally

CBD

Placebo supplementation DIETARY_SUPPLEMENT

Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loughborough University: lead
• Bridge Farm Nurseries Limited, Spalding, UK: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE113TU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Cannabidiol; Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Lewis J James, PhD

CONTACT

00441509226305; L.James@lboro.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Nutrition

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 17, 2023
• Study Start: January 20, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 5, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Permanently, after publication of study findings.

Locations

GB (1)