DiabetesNCT05285449
Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
A study testing Cannabidiol (CBD) powder formulation in people with Diabetes, run by Christopher Bell at 1 site in United States.
Trial summary
While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Cannabidiol (CBD) powder formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 31 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Weight more than 110 pounds
- Have a Body Mass Index greater than or equal to 25 kilograms/squared meters
- Free of gastrointestinal or metabolic diseases
- Sedentary (less than 150 minutes of moderate-intensity exercise per week during the previous 3 months)
Who cannot join
- Less than 18 years of age
- Pregnant or breastfeeding
- Have known food allergies
- Have been diagnosed with any autoimmune disorders or with compromised immune function
- Celiac disease
- Inflammatory bowel diseases
Show all 31Show fewer
- Gastrointestinal cancers
- Diabetes
- Human Immunodeficiency Virus
- Adverse reaction to ingesting CBD oils, or CBD containing food products
- Taking any of the following medications will be excluded as these may have negative interactions with CBD:
- steroids,
- 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors,
- calcium channel blockers,
- antihistamines,
- human immunodeficiency virus antivirals
- immune modulators,
- benzodiazepines,
- antiarrythmics,
- antibiotics,
- anesthetics,
- antipsychotics,
- antidepressants,
- anti-epileptics,
- beta blockers,
- coumadin (warfarin),
- proton pump inhibitors,
- non-steroidal anti-inflammatory drugs,
- angiotension II blockers,
- oral hypoglycemic agents,
- sulfonylureas.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582
About this study
While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. We hope to learn if CBD can improve glucose tolerance and the gut microbiota, and if these two improvements might be related.
Read the detailed description
More than 122 million Americans have diabetes, or its precursor, pre-diabetes. The clinical and public health implications are not trivial as diabetes is the leading cause of blindness and non-traumatic amputation; it is closely associated with vascular disease and premature death, and people with diabetes are at greater risk of serious and fatal complications associated with Covid-19. The defining feature of diabetes is dysfunctional regulation of blood glucose (blood sugar). Although numerous factors contribute to the development of type 2 diabetes, the gut microbiota has recently emerged as an important regulator of glucose homeostasis. Imbalances in the microbiota can lead to intestinal inflammation and loss of gut barrier integrity, which in turn activates inflammatory cascades outside of the gut that can precipitate development of metabolic dysfunction. Changes in the gut microbiota can also alter proportions of microbial metabolites such as secondary bile acids and short chain fatty acids, which have been shown to influence host metabolism. Diet is one of the most important modifiers of the gut microbiota and several plant-based chemicals have been shown to exert beneficial effects on its composition and function. Cannabis sativa L., which produces a suite of phytochemicals, referred to collectively as cannabinoids, has also been shown in epidemiologic studies to exert beneficial effects on glucose regulation. These effects may be, in part, due to interactions with the gut microbiota. The focus of this project is cannabidiol (often abbreviated as CBD). CBD is not marijuana. CBD is not cannabis. CBD is a bioactive phytochemical that is present in the plant Cannabis sativa; it has no psychoactive properties. Over recent years CBD has garnered considerable attention on account of its potential medicinal properties. There is increasing evidence that CBD may have therapeutic and/or preventative effects pertinent to cancer, cardiovascular disease, anxiety, and most relevant to the current proposal, diabetes and the gut microbiota. The aim of the proposed study is to evaluate the influence of short-term CBD on glucose tolerance and the gut microbiota. Hypothesis: compared with daily ingestion of a placebo, 4-weeks daily ingestion of CBD will improve glucose tolerance and favorably modify the gut microbiota towards a more anti-inflammatory profile.
- Conditions
- Diabetes
- Being tested
- Cannabidiol (CBD) powder formulation, Matching Placebo Cannabidiol (CBD) powder formulation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) powder formulationDietary supplement
Also called T-P-S-10 Caliper powder
30 mg CBD in the form of 300 mg of 10% CBD isolate
Matching Placebo Cannabidiol (CBD) powder formulationDietary supplement
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Cannabidiol (CBD) powder formulation | Active comparator | T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate Receives: Dietary Supplement: Cannabidiol (CBD) powder formulation |
| Dietary Supplement: CBD matching Placebo | Placebo comparator | Matching Placebo Receives: Dietary Supplement: Matching Placebo Cannabidiol (CBD) powder formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating blood glucose
Measurements of circulating blood glucose during an Oral Glucose Tolerance Tests via a blood analyzer
Measured: Compared to baseline after 4 weeks of the intervention
Circulating blood insulin
Measurements of circulating insulin during an Oral Glucose Tolerance Tests via a blood analyzer
Measured: Compared to baseline after 4 weeks of the intervention
Hepatic Insulin Extraction
Measurements of C-Peptide concentration via ELISA Assays
Measured: Compared to baseline after 4 weeks of the intervention
Tissue oxygenation
Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)
Measured: Compared to baseline after 4 weeks of the intervention
Reactive hyperemia
Measurement of reactive hyperemia via doppler ultrasound
Measured: Compared to baseline after 4 weeks of the intervention
Shannon and Faith's microbiota diversity scores in feces
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Measured: Compared to baseline after 4 weeks of the intervention
B-diversity scores for all fecal samples to assess clustering
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Measured: Compared to baseline after 4 weeks of the intervention
Differentially abundant microbiota in feces of collected during treatment
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Measured: Compared to baseline after 4 weeks of the intervention
Abundant microbiota to markers in feces
Assessed via Linear discriminant analysis Effect Size algorithm
Measured: Compared to baseline after 4 weeks of the intervention
Human Granulocyte Macrophage Colony-Stimulating Factor
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interferon gamma
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 1 beta
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 2
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 4
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 5
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 6
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 7
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 8
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 10
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 12 (p70)
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Interleukin 13
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Tumor Necrosis Factor alpha
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
High-sensitivity C-reactive protein
Assessed via 13-plex human T-cell cytokine panel
Measured: Compared to baseline after 4 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start9 Feb 2022
- Primary completion9 Mar 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind random assignment to either placebo or active CBD (2 x 30 mg daily)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Collaborators
- Caliper Foods
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285449
- Sponsor's protocol ID
- 2065
- Status last verified
- Jul 2024
- First submitted
- 9 Mar 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
- ClinicalTrials.gov ID
- NCT05285449
- Acronym / sponsor ID
- 2065
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Collaborators
- Caliper Foods
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 17 Mar 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.
While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. We hope to learn if CBD can improve glucose tolerance and the gut microbiota, and if these two improvements might be related.
Detailed description
More than 122 million Americans have diabetes, or its precursor, pre-diabetes. The clinical and public health implications are not trivial as diabetes is the leading cause of blindness and non-traumatic amputation; it is closely associated with vascular disease and premature death, and people with diabetes are at greater risk of serious and fatal complications associated with Covid-19. The defining feature of diabetes is dysfunctional regulation of blood glucose (blood sugar). Although numerous factors contribute to the development of type 2 diabetes, the gut microbiota has recently emerged as an important regulator of glucose homeostasis. Imbalances in the microbiota can lead to intestinal inflammation and loss of gut barrier integrity, which in turn activates inflammatory cascades outside of the gut that can precipitate development of metabolic dysfunction. Changes in the gut microbiota can also alter proportions of microbial metabolites such as secondary bile acids and short chain fatty acids, which have been shown to influence host metabolism. Diet is one of the most important modifiers of the gut microbiota and several plant-based chemicals have been shown to exert beneficial effects on its composition and function. Cannabis sativa L., which produces a suite of phytochemicals, referred to collectively as cannabinoids, has also been shown in epidemiologic studies to exert beneficial effects on glucose regulation. These effects may be, in part, due to interactions with the gut microbiota. The focus of this project is cannabidiol (often abbreviated as CBD). CBD is not marijuana. CBD is not cannabis. CBD is a bioactive phytochemical that is present in the plant Cannabis sativa; it has no psychoactive properties. Over recent years CBD has garnered considerable attention on account of its potential medicinal properties. There is increasing evidence that CBD may have therapeutic and/or preventative effects pertinent to cancer, cardiovascular disease, anxiety, and most relevant to the current proposal, diabetes and the gut microbiota. The aim of the proposed study is to evaluate the influence of short-term CBD on glucose tolerance and the gut microbiota. Hypothesis: compared with daily ingestion of a placebo, 4-weeks daily ingestion of CBD will improve glucose tolerance and favorably modify the gut microbiota towards a more anti-inflammatory profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind random assignment to either placebo or active CBD (2 x 30 mg daily)
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Cannabidiol (CBD) powder formulation | Active comparator | Dietary Supplement: Cannabidiol (CBD) powder formulationT-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate |
| Dietary Supplement: CBD matching Placebo | Placebo comparator | Dietary Supplement: Matching Placebo Cannabidiol (CBD) powder formulationMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Weight more than 110 pounds
- Have a Body Mass Index greater than or equal to 25 kilograms/squared meters
- Free of gastrointestinal or metabolic diseases
- Sedentary (less than 150 minutes of moderate-intensity exercise per week during the previous 3 months)
Key exclusion criteria (31 listed)
- Less than 18 years of age
- Pregnant or breastfeeding
- Have known food allergies
- Have been diagnosed with any autoimmune disorders or with compromised immune function
- Celiac disease
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) powder formulationAlso: T-P-S-10 Caliper powder30 mg CBD in the form of 300 mg of 10% CBD isolate | Dietary supplement | Dietary Supplement: Cannabidiol (CBD) powder formulation |
| Matching Placebo Cannabidiol (CBD) powder formulationMatching Placebo | Dietary supplement | Dietary Supplement: CBD matching Placebo |
Primary outcome
Circulating blood glucose
Time frame: Compared to baseline after 4 weeks of the intervention
Measurements of circulating blood glucose during an Oral Glucose Tolerance Tests via a blood analyzer
Circulating blood insulin
Time frame: Compared to baseline after 4 weeks of the intervention
Measurements of circulating insulin during an Oral Glucose Tolerance Tests via a blood analyzer
Hepatic Insulin Extraction
Time frame: Compared to baseline after 4 weeks of the intervention
Measurements of C-Peptide concentration via ELISA Assays
Tissue oxygenation
Time frame: Compared to baseline after 4 weeks of the intervention
Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)
Reactive hyperemia
Time frame: Compared to baseline after 4 weeks of the intervention
Measurement of reactive hyperemia via doppler ultrasound
Shannon and Faith's microbiota diversity scores in feces
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
B-diversity scores for all fecal samples to assess clustering
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Differentially abundant microbiota in feces of collected during treatment
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
Abundant microbiota to markers in feces
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via Linear discriminant analysis Effect Size algorithm
Human Granulocyte Macrophage Colony-Stimulating Factor
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interferon gamma
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 1 beta
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 2
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 4
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 5
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 6
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 7
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 8
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 10
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 12 (p70)
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Interleukin 13
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
Tumor Necrosis Factor alpha
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
High-sensitivity C-reactive protein
Time frame: Compared to baseline after 4 weeks of the intervention
Assessed via 13-plex human T-cell cytokine panel
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 3 Jul 2024.
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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 Cannabidiol (CBD) powder formulation in people with Diabetes, run by Christopher Bell at 1 site in United States.
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 5 inclusion and 31 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 3 Jul 2024. 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 States. 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?
Circulating blood glucose (time frame: Compared to baseline after 4 weeks of the intervention). The study lists 23 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 3 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.