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CBD, Nutrient Metabolism and Energy Intake

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acute oral CBD supplementation
Acute oral placebo supplementation
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glucose Metabolism Disorders (Including Diabetes Mellitus)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabidiol

Placebo

Arm Description

300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules.

1 ml hemp oil. Provided orally in gelatin capsules.

Outcomes

Primary Outcome Measures

Energy intake
Self-selected energy intake at an ad libitum mixed meal
Postprandial Glycaemia
Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)
Postprandial Triglyceridaemia
Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2022
Last Updated
August 14, 2023
Sponsor
Loughborough University
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1. Study Identification

Unique Protocol Identification Number
NCT05618756
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorders, Appetitive Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 ml hemp oil. Provided orally in gelatin capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Acute oral CBD supplementation
Intervention Description
1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.
Intervention Type
Dietary Supplement
Intervention Name(s)
Acute oral placebo supplementation
Intervention Description
1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.
Primary Outcome Measure Information:
Title
Energy intake
Description
Self-selected energy intake at an ad libitum mixed meal
Time Frame
~5-30 minutes (time taken to eat a single meal)
Title
Postprandial Glycaemia
Description
Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)
Time Frame
3 hours
Title
Postprandial Triglyceridaemia
Description
Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Postprandial Insulinaemia
Description
Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CBD, Nutrient Metabolism and Energy Intake

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