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CBD, Nutrient Metabolism and Energy Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05618756
Recruitment Status : Active, not recruiting
First Posted : November 16, 2022
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
Lewis James, Loughborough University

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Glucose Metabolism Disorders (Including Diabetes Mellitus) Lipid Metabolism Disorders Appetitive Behavior Dietary Supplement: Acute oral CBD supplementation Dietary Supplement: Acute oral placebo supplementation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : March 30, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol
300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules.
 Dietary Supplement: Acute oral CBD supplementation
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.
 Dietary Supplement: Acute oral placebo supplementation
1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.


Outcome Measures
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Primary Outcome Measures :
  1. Energy intake [ Time Frame: ~5-30 minutes (time taken to eat a single meal) ]
    Self-selected energy intake at an ad libitum mixed meal

  2. Postprandial Glycaemia [ Time Frame: 3 hours ]
    Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)

  3. Postprandial Triglyceridaemia [ Time Frame: 3 hours ]
    Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)


Secondary Outcome Measures :
  1. Postprandial Insulinaemia [ Time Frame: 3 hours ]
    Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05618756


Locations
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United Kingdom
Loughborough University
Loughborough, Leicestershire, United Kingdom, LE11 3TU
Sponsors and Collaborators
Loughborough University
More Information
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Responsible Party: Lewis James, Senior Lecturer in Nutrition, Loughborough University
ClinicalTrials.gov Identifier: NCT05618756    
Other Study ID Numbers: 5553
First Posted: November 16, 2022    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders