Appetitive BehaviorNCT05774574
Physiological and Appetitive Effects of CBD Supplementation
A study testing Cannabidiol (CBD) supplementation in people with Appetitive Behavior and Adverse Effect, run by Loughborough University at 1 site in United Kingdom.
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 four weeks of supplementation with 60 mg/day CBD affects energy intake at a single meal, and or fasting blood-based markers of appetite… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Adverse Effect, Metabolic Health
- What is being tested?
- Cannabidiol (CBD) supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2023to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, aged 18-50, who do not meet the exclusion criteria
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Loughborough University
Loughborough, Leicestershire, LE113TU
Lewis J James, PhD, 00441509226305, L.James@lboro.ac.uk
About this study
Official title: Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population
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.
- Conditions
- Appetitive Behavior, Adverse Effect, Metabolic Health
- Being tested
- Cannabidiol (CBD) supplementation, Placebo supplementation
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) supplementationDietary supplement
Daily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally
Placebo supplementationDietary supplement
Daily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally
| Study group | Role | What they receive |
|---|---|---|
| CBD | Experimental | 1 mL hemp oil containing 60 mg/mL CBD, daily. Receives: Dietary Supplement: Cannabidiol (CBD) supplementation |
| Placebo | Placebo comparator | 1 mL hemp oil containing 0 mg/mL CBD, daily. Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake
Self-selected energy intake at an ad libitum mixed meal
Measured: Baseline and after 4 weeks supplementation
Secondary outcomes (9)
CBD
CBD circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Liver transaminases
AST and ALT circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Hormones implicated in appetite regulation
Hormones implicated in appetite regulation (e.g., leptin and ghrelin) circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Lipoproteins
Lipoproteins (e.g., total cholesterol, HDL-C and LDL-C) circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Glucose
Glucose circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Triglycerides
Triglycerides circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Insulin
Insulin circulating in plasma
Measured: Baseline and after 4 weeks supplementation
Subjective appetite (hunger, fullness, desire to eat)
Measured using pen and paper scales (scored 'not at all' [0 mm] to 'extremely' [100 mm])
Measured: Baseline and after 4 weeks supplementation
self-reported adverse events
Adverse events reported in diary by participants
Measured: During 4 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start20 Jan 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion5 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Bridge Farm Nurseries Limited, Spalding, UK
- Responsible party
- Principal investigator, Lewis James, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774574
- Sponsor's protocol ID
- 11031
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data for study outcomes will be shared on the Loughborough University Research Repository
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Appetitive Effects of Four Weeks of 60 mg/Day CBD Supplementation in an Adult Population
- ClinicalTrials.gov ID
- NCT05774574
- Acronym / sponsor ID
- 11031
- Conditions
- Appetitive Behavior, Adverse Effect, Metabolic Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Bridge Farm Nurseries Limited, Spalding, UK
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 5 Jan 2024 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD | Experimental | Dietary Supplement: Cannabidiol (CBD) supplementation1 mL hemp oil containing 60 mg/mL CBD, daily. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementation1 mL hemp oil containing 0 mg/mL CBD, daily. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males and females, aged 18-50, who do not meet the exclusion criteria
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD) supplementationDaily supplementation with 1 ml hemp oil containing 60 mg CBD, applied orally | Dietary supplement | CBD |
| Placebo supplementationDaily supplementation with 1 ml hemp oil containing 0 mg CBD, applied orally | Dietary supplement | Placebo |
Primary outcome
Energy Intake
Time frame: Baseline and after 4 weeks supplementation
Self-selected energy intake at an ad libitum mixed meal
9 secondary outcomes
CBD
Time frame: Baseline and after 4 weeks supplementation
Liver transaminases
Time frame: Baseline and after 4 weeks supplementation
Hormones implicated in appetite regulation
Time frame: Baseline and after 4 weeks supplementation
Lipoproteins
Time frame: Baseline and after 4 weeks supplementation
Glucose
Time frame: Baseline and after 4 weeks supplementation
Triglycerides
Time frame: Baseline and after 4 weeks supplementation
Insulin
Time frame: Baseline and after 4 weeks supplementation
Subjective appetite (hunger, fullness, desire to eat)
Time frame: Baseline and after 4 weeks supplementation
self-reported adverse events
Time frame: During 4 weeks supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual data for study outcomes will be shared on the Loughborough University Research Repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol (CBD) supplementation in people with Appetitive Behavior and Adverse Effect, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lewis J James, PhD (00441509226305, L.James@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Intake (time frame: Baseline and after 4 weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.