- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05285449
Influence of Cannabidiol on Glucose Tolerance and The Gut Microbiota
May 15, 2023 updated by: Christopher Bell
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.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christopher Bell, PhD
- Phone Number: 970-491-7522
- Email: christopher.bell@colostate.edu
Study Contact Backup
- Name: Taylor Ewell, MS
- Email: Taylor.Ewell@colostate.edu
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1582
- Colorado State University, Dept. of Health and Exercise Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dietary Supplement: Cannabidiol (CBD) powder formulation
T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate
|
30 mg CBD in the form of 300 mg of 10% CBD isolate
Other Names:
|
Placebo Comparator: Dietary Supplement: CBD matching Placebo
Matching Placebo
|
Matching Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
Hepatic Insulin Extraction
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Measurements of C-Peptide concentration via ELISA Assays
|
Compared to baseline after 4 weeks of the intervention
|
Tissue oxygenation
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Measurement of tissue oxygenation via Near-Infrared Spectroscopy (NIRS)
|
Compared to baseline after 4 weeks of the intervention
|
Reactive hyperemia
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Measurement of reactive hyperemia via doppler ultrasound
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
Interferon gamma
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 1 beta
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 2
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 4
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 5
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 6
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 7
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 8
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 10
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 12 (p70)
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Interleukin 13
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
Tumor Necrosis Factor alpha
Time Frame: Compared to baseline after 4 weeks of the intervention
|
Assessed via 13-plex human T-cell cytokine panel
|
Compared to baseline after 4 weeks of the intervention
|
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
|
Compared to baseline after 4 weeks of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2022
Primary Completion (Actual)
March 9, 2023
Study Completion (Anticipated)
March 9, 2024
Study Registration Dates
First Submitted
March 9, 2022
First Submitted That Met QC Criteria
March 9, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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