History of Changes for Study: NCT05618756

CBD, Nutrient Metabolism and Energy Intake

Latest version (submitted August 14, 2023) on ClinicalTrials.gov

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	November 9, 2022	None (earliest Version on record)
2	January 16, 2023	Study Status
3	August 14, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Scroll up to access the controls

Study NCT05618756
Submitted Date: November 9, 2022 (v1)

Study Identification


Unique Protocol ID:	5553
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
Secondary IDs:

Study Status


Record Verification:	November 2022
Overall Status:	Recruiting
Study Start:	October 1, 2021
Primary Completion:	December 1, 2022 [Anticipated]
Study Completion:	October 1, 2023 [Anticipated]

First Submitted:	February 23, 2022
First Submitted that Met QC Criteria:	November 9, 2022
First Posted:	November 16, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	November 9, 2022
Last Update Posted:	November 16, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Loughborough University
Responsible Party:	Principal Investigator Investigator: Lewis James Official Title: Senior Lecturer in Nutrition Affiliation: Loughborough University
Collaborators:

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.

Detailed Description:

Conditions


Conditions:	Glucose Metabolism Disorders (Including Diabetes Mellitus) Lipid Metabolism Disorders Appetitive Behavior
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Crossover Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	20 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 [ 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


Minimum Age:	18 Years
Maximum Age:	50 Years
Sex:	All
Gender Based:
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/Locations


Locations:	United Kingdom, Leicestershire
	Loughborough University [Recruiting] Loughborough, Leicestershire, United Kingdom, LE11 3TU Contact:Contact: Lewis James, PhD +441509226305 l.james@lboro.ac.uk Contact:Principal Investigator: Lewis James, PhD Contact:Sub-Investigator: Drusus Johnson, MSci

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services