Physiological and Appetitive Effects of CBD Supplementation

NCT ID: NCT05774574

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2024-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Appetitive Behavior Adverse Effect Metabolic Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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CBD

1 mL hemp oil containing 60 mg/mL CBD, daily.

Group Type EXPERIMENTAL

Cannabidiol (CBD) supplementation

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally

Placebo

1 mL hemp oil containing 0 mg/mL CBD, daily.

Group Type PLACEBO_COMPARATOR

Placebo supplementation

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally

Interventions

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Cannabidiol (CBD) supplementation

Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation

Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bridge Farm Nurseries Limited, Spalding, UK

UNKNOWN

Sponsor Role collaborator

Loughborough University

OTHER

Sponsor Role lead

Responsible Party

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Lewis James

Senior Lecturer in Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loughborough University

Loughborough, Leicestershire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Lewis J James, PhD

Role: CONTACT

00441509226305

Facility Contacts

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Lewis J James, PhD

Role: primary

00441509226305

Other Identifiers

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11031

Identifier Type: -

Identifier Source: org_study_id

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