CBD, Nutrient Metabolism and Energy Intake

• Sponsor: Loughborough University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05618756
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 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: Oct 1, 2021
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Energy intake [~5-30 minutes (time taken to eat a single meal)]

   Self-selected energy intake at an ad libitum mixed meal

2. Postprandial Glycaemia [3 hours]

   Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)

3. Postprandial Triglyceridaemia [3 hours]

   Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)

Secondary Outcome Measures

1. Postprandial Insulinaemia [3 hours]

   Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Loughborough University	Loughborough	Leicestershire	United Kingdom	LE11 3TU

Sponsors and Collaborators

• Loughborough University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lewis James, Senior Lecturer in Nutrition, Loughborough University
• ClinicalTrials.gov Identifier: NCT05618756
• Other Study ID Numbers: 5553
• First Posted: Nov 16, 2022
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Disease

Study Results

No Results Posted as of Jan 18, 2023