CBD, Nutrient Metabolism and Energy Intake

NCT05618756 | Completed

• 1 other identifier: 5553
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Energy intake

  Self-selected energy intake at an ad libitum mixed meal

  ~5-30 minutes (time taken to eat a single meal)

• Postprandial Glycaemia

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

  3 hours

• Postprandial Triglyceridaemia

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

  3 hours

Secondary Outcomes (1)

• Postprandial Insulinaemia

  3 hours

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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

Dietary Supplement: Acute oral CBD supplementation

Placebo

PLACEBO COMPARATOR

1 ml hemp oil. Provided orally in gelatin capsules.

Dietary Supplement: Acute oral placebo supplementation

Interventions

Acute oral CBD supplementation DIETARY_SUPPLEMENT

1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.

Cannabidiol

Acute oral placebo supplementation DIETARY_SUPPLEMENT

1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and \<30.0

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders; Lipid Metabolism Disorders; Appetitive Behavior

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Nutrition

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: November 16, 2022
• Study Start: September 30, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)