Physiological and Appetitive Effects of CBD Supplementation

• Sponsor: Loughborough University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05774574
• Collaborator: Bridge Farm Nurseries Limited, Spalding, UK (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 2.6

Study Details

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 four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite regulation and metabolic health. Healthy, adult volunteers will be assigned to placebo or CBD supplementation, in a randomized controlled trial, comparing changes in outcomes across the supplementation period between groups.

Condition or Disease	Intervention/Treatment	Phase
Appetitive Behavior; Adverse Effect; Metabolic Health	Dietary Supplement: Cannabidiol (CBD) supplementation; Dietary Supplement: Placebo supplementation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind
• Primary Purpose: Prevention
• Official Title: Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population
• Actual Study Start Date: Jan 20, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Jan 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBD 1 mL hemp oil containing 60 mg/mL CBD, daily.	Dietary Supplement: Cannabidiol (CBD) supplementation; Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally
Placebo Comparator: Placebo 1 mL hemp oil containing 0 mg/mL CBD, daily.	Dietary Supplement: Placebo supplementation; Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally

Outcome Measures

Primary Outcome Measures

1. Energy Intake [Baseline and after 4 weeks supplementation]

   Self-selected energy intake at an ad libitum mixed meal

Secondary Outcome Measures

1. CBD [Baseline and after 4 weeks supplementation]

   CBD circulating in plasma

2. Liver transaminases [Baseline and after 4 weeks supplementation]

   AST and ALT circulating in plasma

3. Hormones implicated in appetite regulation [Baseline and after 4 weeks supplementation]

   Hormones implicated in appetite regulation (e.g., leptin and ghrelin) circulating in plasma

4. Lipoproteins [Baseline and after 4 weeks supplementation]

   Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma

5. Glucose [Baseline and after 4 weeks supplementation]

   Glucose circulating in plasma

6. Triglycerides [Baseline and after 4 weeks supplementation]

   Triglycerides circulating in plasma

7. Insulin [Baseline and after 4 weeks supplementation]

   Insulin circulating in plasma

8. Subjective appetite (hunger, fullness, desire to eat) [Baseline and after 4 weeks supplementation]

   Measured using pen and paper scales (scored 'not at all' [0 mm] to 'extremely' [100 mm])

9. self-reported adverse events [During 4 weeks supplementation]

   Adverse events reported in diary by participants

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Exclusion Criteria:

• No history of any substance abuse

• Have used tobacco regularly (>2x in a week) within the past 6 months

• Are suffering from any condition that may affect study outcomes

• 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 we provide during the study (relevant allergens: oats, milk)

Inclusion Criteria:

• Males and females, aged 18-50, who do not meet the exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loughborough University	Loughborough	Leicestershire	United Kingdom	LE113TU

Sponsors and Collaborators

• Loughborough University
• Bridge Farm Nurseries Limited, Spalding, UK

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lewis James, Senior Lecturer in Nutrition, Loughborough University
• ClinicalTrials.gov Identifier: NCT05774574
• Other Study ID Numbers: 11031
• First Posted: Mar 17, 2023
• Last Update Posted: Mar 17, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cannabidiol

Study Results

No Results Posted as of Mar 17, 2023