CBD, Nutrient Metabolism and Energy Intake

• ClinicalTrials.gov Identifier: NCT05618756
• Recruitment Status: Active, not recruiting
• First Posted: November 16, 2022
• Last Update Posted: August 15, 2023
• Sponsor: Loughborough University
• Information provided by (Responsible Party): Lewis James, Loughborough University

Tracking Information

• First Submitted Date: February 23, 2022
• First Posted Date: November 16, 2022
• Last Update Posted Date: August 15, 2023
• Actual Study Start Date: October 1, 2021
• Actual Primary Completion Date: March 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2022)

• Energy intake [ Time Frame: ~5-30 minutes (time taken to eat a single meal) ]
  Self-selected energy intake at an ad libitum mixed meal
• Postprandial Glycaemia [ Time Frame: 3 hours ]
  Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)
• Postprandial Triglyceridaemia [ Time Frame: 3 hours ]
  Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 9, 2022)

Postprandial Insulinaemia [ Time Frame: 3 hours ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CBD, Nutrient Metabolism and Energy Intake
• Official Title: Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Lipid Metabolism Disorders
• Appetitive Behavior

Intervention

• Dietary Supplement: Acute oral CBD supplementation
  1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.
• Dietary Supplement: Acute oral placebo supplementation
  1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.

Study Arms

• Experimental: Cannabidiol
  300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules.
  Intervention: Dietary Supplement: Acute oral CBD supplementation
• Placebo Comparator: Placebo
  1 ml hemp oil. Provided orally in gelatin capsules.
  Intervention: Dietary Supplement: Acute oral placebo supplementation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 14, 2023): 15
• Original Estimated Enrollment (submitted: November 9, 2022): 20
• Estimated Study Completion Date: August 31, 2023
• Actual Primary Completion Date: March 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05618756
• Other Study ID Numbers: 5553
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lewis James, Loughborough University
• Original Responsible Party: Same as current
• Current Study Sponsor: Loughborough University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Loughborough University
• Verification Date: August 2023