- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05618756
CBD, Nutrient Metabolism and Energy Intake
February 4, 2025 updated by: Lewis James, Loughborough University
Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults
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 a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal.
Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and <30.0
Exclusion Criteria:
- Currently engage in >10 hours moderate or vigorous intensity physical activity per week
- Have consumed CBD or cannabis at all within the past two months
- Have used CBD or cannabis regularly (>2x in a week) within the past four months
- Are suffering from any clinically significant illness
- Have regularly used tobacco within the previous 6 months (> 2/week)
- 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 provided during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cannabidiol
300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil.
Provided orally in gelatin capsules.
|
1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.
|
|
Placebo Comparator: Placebo
1 ml hemp oil.
Provided orally in gelatin capsules.
|
1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy intake
Time Frame: ~5-30 minutes (time taken to eat a single meal)
|
Self-selected energy intake at an ad libitum mixed meal
|
~5-30 minutes (time taken to eat a single meal)
|
|
Postprandial Glycaemia
Time Frame: 3 hours
|
Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)
|
3 hours
|
|
Postprandial Triglyceridaemia
Time Frame: 3 hours
|
Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Insulinaemia
Time Frame: 3 hours
|
Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
February 23, 2022
First Submitted That Met QC Criteria
November 9, 2022
First Posted (Actual)
November 16, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 4, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5553 (Other Identifier: COMITATO ETICO TERRITORIALE LOMBARDIA 3)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.