Glucose Metabolism Disorders (Including Diabetes Mellitus)NCT05618756
CBD, Nutrient Metabolism and Energy Intake
A study testing Acute oral CBD supplementation in people with Glucose Metabolism Disorders (Including Diabetes Mellitus) and Lipid Metabolism Disorders, 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 a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorders, Appetitive Behavior
- What is being tested?
- Acute oral CBD supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2021to 30 Apr 2022
- 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
- Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and <30.0
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults
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
- Being tested
- Acute oral CBD supplementation, Acute oral placebo supplementation
- Medical subject headings
- Glucose Metabolism Disorders, Lipid Metabolism Disorders, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute oral CBD supplementationDietary supplement
1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally.
Acute oral placebo supplementationDietary supplement
1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | 300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules. Receives: Dietary Supplement: Acute oral CBD supplementation |
| Placebo | Placebo comparator | 1 ml hemp oil. Provided orally in gelatin capsules. Receives: Dietary Supplement: Acute oral 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: ~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)
Measured: 3 hours
Postprandial Triglyceridaemia
Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)
Measured: 3 hours
Secondary outcomes (1)
Postprandial Insulinaemia
Plasma Insulin response to a mixed meal (plasma insulin concentrations and area under curve)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start30 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lewis James, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618756
- Sponsor's protocol ID
- 5553
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Cannabidiol (CBD) Supplementation on Nutrient Metabolism and Energy Intake in Healthy Adults
- ClinicalTrials.gov ID
- NCT05618756
- Acronym / sponsor ID
- 5553
- Conditions
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorders, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 16 Nov 2022 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Dietary Supplement: Acute oral CBD supplementation300 mg CBD (KannaSwiss, Kölliken, Switzerland) dissolved in 1 ml hemp oil. Provided orally in gelatin capsules. |
| Placebo | Placebo comparator | Dietary Supplement: Acute oral placebo supplementation1 ml hemp oil. Provided orally in gelatin capsules. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self-report as healthy, male or female, aged 18-50, body mass index ≥18.5 and <30.0
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Acute oral CBD supplementation1 ml hemp oil containing 300 mg CBD, within gelatin capsules, ingested orally. | Dietary supplement | Cannabidiol |
| Acute oral placebo supplementation1 ml hemp oil containing no CBD, within gelatin capsules, ingested orally. | Dietary supplement | Placebo |
Primary outcome
Energy intake
Time frame: ~5-30 minutes (time taken to eat a single meal)
Self-selected energy intake at an ad libitum mixed meal
Postprandial Glycaemia
Time frame: 3 hours
Plasma glucose response to a mixed meal (plasma glucose concentrations and area under curve)
Postprandial Triglyceridaemia
Time frame: 3 hours
Plasma triglyceride response to a mixed meal (plasma triglyceride concentrations and area under curve)
1 secondary outcome
Postprandial Insulinaemia
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute oral CBD supplementation in people with Glucose Metabolism Disorders (Including Diabetes Mellitus) and Lipid Metabolism Disorders, 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 9 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: finished, as of the sponsor's last update on 6 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: ~5-30 minutes (time taken to eat a single meal)). The study lists 3 primary outcomes in all. 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 6 Feb 2025.