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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05618756
Other study ID # 5553
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date August 31, 2023

Study information

Verified date August 2023
Source Loughborough University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date August 31, 2023
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Loughborough University Loughborough Leicestershire

Sponsors (1)

Lead Sponsor Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Energy intake Self-selected energy intake at an ad libitum mixed meal ~5-30 minutes (time taken to eat a single meal)
Primary Postprandial Glycaemia Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve) 3 hours
Primary Postprandial Triglyceridaemia Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve) 3 hours
Secondary Postprandial Insulinaemia Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve) 3 hours
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